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Methods and compositions for treating recurrent cancer

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20140017316 patent thumbnailZoom

Methods and compositions for treating recurrent cancer


The present invention provides methods of treating recurrent cancer (such as recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition (such as Nab-paclitaxel or Abraxane®) comprising nanoparticles comprising a taxane and a carrier protein.
Related Terms: Nanoparticle Fallopian Tube Fallopian Tube Cancer Ovarian Paclitaxel Peritoneal Recur Recurrent Taxane

Browse recent Abraxis Bioscience, LLC patents - Los Angeles, CA, US
USPTO Applicaton #: #20140017316 - Class: 424489 (USPTO) -
Drug, Bio-affecting And Body Treating Compositions > Preparations Characterized By Special Physical Form >Particulate Form (e.g., Powders, Granules, Beads, Microcapsules, And Pellets)



Inventors: Neil P. Desai, Patrick Soon-shiong

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The Patent Description & Claims data below is from USPTO Patent Application 20140017316, Methods and compositions for treating recurrent cancer.

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CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the priority benefit of the U.S. Provisional Patent Application No. 60/932,750 filed on Jun. 1, 2007, the content of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

The present invention relates to methods and compositions for the treatment of recurrent cancer, particularly recurrent ovarian cancer, comprising the administration of compositions comprising nanoparticles comprising taxane and a carrier protein (such as albumin).

BACKGROUND

Ovarian cancer forms in tissues of an ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells). According to the National Cancer Institute, ovarian cancer is the seventh most common cancer, with an estimated 20,180 new cases in 2006, but is the fourth most deadly, with an estimated 15,310 deaths in 2006.

A possible genetic contribution to ovarian cancer risk is indicated by the increased incidence of this cancer among women with a family history, and by the observation of rare families in which multiple family members are affected with ovarian cancer, in a pattern compatible with autosomal dominant inheritance of cancer susceptibility. Formal studies of families (linkage analysis) have subsequently proven the existence of autosomal dominant predispositions to ovarian cancer and have led to the identification of several highly penetrant genes as the cause of inherited cancer risk in many cancer-prone families. Mutations in these genes are rare in the general population and are estimated to account for no more than 5% to 10% of ovarian cancer cases overall.

Although reproductive, demographic, and lifestyle factors affect risk of ovarian cancer, the single greatest ovarian cancer risk factor is a family history of the disease. A large meta-analysis of 15 published studies estimated an odds ratio (OR) of 3.1 for the risk of ovarian cancer associated with at least one first-degree relative with ovarian cancer.

Despite recent improvements, initial or first-line chemotherapy fails to produce a remission in more than 70% of patients with ovarian cancer. Furthermore, approximately 40-50% of the women who do achieve a remission after first-line chemotherapy will experience a recurrence of cancer within 3 years. Patients with recurrent ovarian, peritoneal, or fallopian tube cancer generally have a poor outcome with current therapies. There is a need for effective treatment method for patients with recurrent ovarian cancers. Preferably, the treatments overcome the shortcomings of current drug and transplant treatments, such as hypersensitivity reactions due to the solvent/surfactant in which drugs are dissolved.

Many anti-proliferative agents are dissolved in a solvent/surfactant which produces hypersensitivity reactions. Great efforts have been invested on the development of water soluble prodrugs and derivatives of anti-proliferative agents with higher hydrophilic groups to enhance water solubility and thus obviate the need for potentially toxic solvents/surfactants. Another approach to address the problem associated with the poor water solubility of anti-proliferative agents is the development of various formulations such as nanoparticles, oil-in-water emulsions, and liposomes. For example, Abraxane® is a nanoparticle composition of paclitaxel and albumin. Nanoparticle compositions of substantially poorly water soluble drugs and uses thereof have been disclosed, for example, in U.S. Pat. Nos. 5,916,596; 6,096,331; 6,749,868; and 6,537,579; U.S. Patent Appln. Pub. No. US20030199425; and PCT Application Pub. Nos. WO98/14174, WO99/00113, WO07/027,941 and WO07/027,819. Administration of Abraxane® to a patient with recurrent ovarian cancer is described in Mida et al., Gynecologic Oncology, 100:437-438 (2006).

The disclosures of all publications, patents, patent applications and published patent applications referred to herein are hereby incorporated herein by reference in their entirety.

BRIEF

SUMMARY

OF THE INVENTION

The present invention provides methods for the treatment of a recurrent cancer (such as a recurrent gynecological cancer) by administering a composition comprising nanoparticles comprising a taxane and a carrier protein (hereinafter referred to as “taxane nanoparticle composition”). In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, the recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) is platinum sensitive. In some embodiments, the recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) is platinum resistant. In some embodiments, the recurrent cancer is a recurrent lung cancer.

In some embodiments, the recurrent cancer is a recurrent gynecological cancer. In some embodiments, the recurrent gynecological cancer is a recurrent ovarian cancer (such as a recurrent epithelial ovarian cancer). In some embodiments, the recurrent gynecological cancer is a recurrent peritoneal cancer. In some embodiments, the recurrent gynecological cancer is a recurrent fallopian tube cancer (including for example papillary serous adenocarcinomas, sarcomas, and transitional cell carcinomas). Other recurrent gynecological cancers such as recurrent malignant mixed mullerian tumor and serous endo can also be treated.

In some embodiments, the individual is a woman who is about 40 to about 85 years old, including for example about 60 to about 70 years old. In some embodiments, the individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (such as any of 0, 1, or 2) prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has received a prior cancer therapy (such as chemotherapy) and has a treatment free interval for more than about any of 3, 6, or 9 months since the completion of prior chemotherapy. In some embodiments, the individual has received a prior cancer therapy (such as chemotherapy) and has a treatment free interval for more than about any of 12, 18, 24, 36, or 48 months since the completion of prior chemotherapy. In some embodiments, the prior chemotherapy has a different mechanism of action than that of the taxane. In some embodiments, the individual has only been treated with platinum-based agent(s) prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has only been treated with one dosing regime prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has not previously been treated with a taxane-based therapy.

In some embodiments, the individual has received a prior cancer therapy (such as chemotherapy) and has a treatment free interval for more than about any of 3, 6, or 9 months prior to the initiation of the methods described herein. In some embodiments, the individual has received a prior cancer therapy (such as chemotherapy) and has a treatment free interval for more than about any of 12, 18, 24, 36, or 48 months prior to the initiation of the methods described herein. In some embodiments, the individual does not show a symptom of hypersensitivity (such as neuropathy) prior to the initiation of the methods described herein (such as within 12, 9, 6, 5, 4, 3, 2, or 1 month prior to the initiation of the methods described herein). In some embodiments, the individual does not show a symptom of hypersensitivity throughout the treatment period with methods described herein. In some embodiments, the individual does not show a symptom of hypersensitivity upon completion of the treatment with methods described herein.

In some embodiments when the method is directed to treatment of a recurrent ovarian, peritoneal, or fallopian tube cancer, the individual may be confirmed of having an ovarian, peritoneal, or fallopian tube cancer histologically or cytologically. In some embodiments, the individual is determined to have an ovarian, peritoneal, or fallopian tube cancer based on RECIST (Response Evaluation Criteria in Solid Tumors). In some embodiments, the individual has an elevated blood level of Cancer Antigen 125 (CA-125, for example a CA-125 level of more than about 40, 50, 60, 70, 80, or 90 units/ml, or about 2×, 3×, 4×, or more of that of the upper limit of a normal CA-125 level). In some embodiments, the individual has an altered level of a marker that is indicative of an ovarian, peritoneal, or fallopian tube cancer.

In some embodiments, the individual satisfies at least two of the criteria described above. For example, in some embodiments, the individual has a measurable disease by RECIST and an elevated blood level of CA-125. In some embodiments, the individual is confirmed of having an ovarian cancer histologically or cytologically and has only been treated with platinum-based agent(s) prior to administration of the nanoparticle compositions described above. In some embodiments, the individual satisfies at least any of two, three, four, five, or more criteria described above. In some embodiments, the individual satisfies all criteria described above.

In some embodiments, the recurrent cancer (such as recurrent ovarian cancer) is platinum-sensitive. For example, in some embodiments, the individual has received prior platinum-based chemotherapy and has a treatment-free interval for more than about any of 3, 6, or 9 months since the completion of the platinum-based chemotherapy. In some embodiments, the individual has received prior platinum-based chemotherapy and has a treatment-free interval for more than about any of 12, 18, 24, 36, or 48 months since the completion of the platinum-based chemotherapy. Platinum-based chemotherapy includes, but is not limited to, treatment with carboplatin, cisplatin, and oxaliplatin. In some embodiments, the platinum-based chemotherapy is treatment with carboplatin.

The methods described herein comprise administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, the taxane nanoparticle composition is administered in conjunction with another chemotherapeutic agent (such as a platinum-based agent). For example, the taxane nanoparticle composition and the other chemotherapeutic agent (such as a platinum-based agent) can be administered sequentially, simultaneously, or concurrently. In some embodiments, the other chemotherapeutic agent (such as platinum-based agent) is administered in the same composition as the nanoparticles comprising taxane and carrier protein. The other chemotherapeutic agent (such as platinum-based agent) can also be formulated into a nanoparticle composition as described herein.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), and b) an effective amount of a platinum-based agent. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual a) an effective amount of a composition comprising nanoparticles comprising paclitaxel and an albumin (such as Abraxane®), and b) an effective amount of a platinum-based agent. Suitable platinum-based agents include, but are not limited to, carboplatin, cisplatin, and oxaliplatin. In some embodiments, the platinum-based agent is carboplatin. In some embodiments, the taxane nanoparticle composition and the platinum-based agent are administered simultaneously. In some embodiments, the taxane nanoparticle composition and the platinum-based agent are administered sequentially. In some embodiments, the taxane nanoparticle composition and the platinum-based agent is administered concurrently.

In some embodiments, there is provided a method of treating a recurrent ovarian cancer in an individual, comprising administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), and b) an effective amount of a platinum-based agent. In some embodiments, there is provided a method of treating a primary peritoneal cancer in an individual, comprising administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), and b) an effective amount of a platinum-based agent.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), and b) an effective amount of a platinum-based agent, wherein the taxane nanoparticle composition and the platinum-based agent are administered concurrently. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual: a) an effective amount of a composition comprising nanoparticles comprising a paclitaxel and an albumin (such as Abraxane®), and b) an effective amount of a platinum-based agent, wherein the paclitaxel nanoparticle composition and the platinum-based agent are administered concurrently.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer, for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering (for example intravenously or intraperitoneally) to the individual: a) an effective amount of a composition comprising nanoparticles comprising a paclitaxel and an albumin (such as Abraxane®), wherein the amount of the paclitaxel in the composition is at least about 40 mg/m2 (including for example about any of 50 mg/m2, 60 mg/m2, 70 mg/m2, 80 mg/m2, 90 mg/m2, 100 mg/m2, 150 mg/m2, or 200 mg/m2); b) an effective amount of a platinum-based agent (such as the platinum-based agent at the amount of AUC3, AUC4, or AUC6), wherein the taxane nanoparticle composition and the platinum-based agent are administered concurrently. In some embodiments, the method comprises administering a composition comprising nanoparticles comprising paclitaxel and an albumin (such as Abraxane®) at about 100 mg/m2, three out of four weeks, and a platinum-based agent (such as carboplatin) AUC6 every four weeks in the same treatment cycle. In some embodiments, the method comprises administering a composition comprising nanoparticles comprising paclitaxel and an albumin (such as Abraxane®) at about 100 mg/m2, three out of four weeks, and a platinum-based agent (such as carboplatin) AUC5 every four weeks in the same treatment cycle. In some embodiments, the method comprises intravenously administering a composition comprising nanoparticles comprising paclitaxel and an albumin (such as Abraxane®) at about 100 mg/m2, three out of four weeks, and intravenously administering a platinum-based agent (such as carboplatin) AUC5 every four weeks in the same treatment cycle. In some embodiments, the individual is treated with at least any of about one, two, three, four, five, six, seven, eight, or more such treatment cycles.

In some embodiments, there is provided a method of treating recurrent ovarian cancer, comprising intravenously administering a composition comprising nanoparticles comprising paclitaxel and an albumin (such as Abraxane®) at about 100 mg/m2, three out of four weeks, and intravenously administering a platinum-based agent (such as carboplatin) AUC5 (or AUC6) every four weeks in the same treatment cycle. In some embodiments, there is provided a method of treating primary peritoneal cancer, comprising intravenously administering a composition comprising nanoparticles comprising paclitaxel and an albumin (such as Abraxane®) at about 100 mg/m2, three out of four weeks, and intravenously administering a platinum-based agent (such as carboplatin) AUC5 (or AUC6) every four weeks in the same treatment cycle. In some embodiments, the individual is treated with at least any of about one, two, three, four, five, six, seven, eight, or more such treatment cycles.

In some embodiments, the taxane nanoparticle composition is not administered in conjunction with a platinum-based agent, that is, the taxane nanoparticle composition is either administered in a monotherapy dosing regime or administered in conjunction with a chemotherapeutic agent other than a platinum-based agent. In some embodiments, a platinum-based agent is not administered to the individual during the time period in which the individual is receiving one or more doses of the taxane nanoparticle composition. In some embodiments, the individual is not treated with a platinum-based agent concurrently with the administration of the taxane nanoparticle composition.

In some embodiments, the taxane nanoparticle composition can be administered alone, that is, the taxane nanoparticle is administered in a monotherapy dosing regime. For example, in some embodiments, the amount of the taxane nanoparticle composition administered alone is sufficient to result in a complete response in the individual. In some embodiments, the amount of the taxane nanoparticle composition administered alone is sufficient to result in a partial response in the individual. In some embodiments, the amount of the taxane nanoparticle composition administered alone is sufficient to produce an overall response rate of more than about any of 40%, 50%, 60%, or 64% among a population of individuals treated with the taxane nanoparticle composition. In some embodiments, the amount of taxane nanoparticle composition administered alone is sufficient to produce clinical benefit of more than about any of 50%, 60%, 70%, or 77% among a population of individuals treated with the taxane nanoparticle composition.

The taxane nanoparticle compositions described herein comprise nanoparticles comprising taxane (such as paclitaxel) and a carrier protein. In some embodiments, the taxane is paclitaxel, docetaxel, ortataxel, or IDN5390. In some embodiments, the carrier protein is albumin, such as human serum albumin. In some embodiments, the weight ratio of the carrier protein to the taxane in the taxane nanoparticle composition is less than about 18:1 (including for example less than about any of 15:1, 12:1, 10:1, such as 9:1).

In some embodiments, the nanoparticles comprise the taxane coated with a coating comprising the carrier protein (such as albumin). In some embodiments, the coating consists essentially of or consists of the carrier protein. In some embodiments, at least a portion of the carrier protein in the nanoparticle portion of the taxane nanoparticle composition is crosslinked (for example crosslinked by disulfide bonds). In some embodiments, the nanoparticles of the composition comprise at least 5% (including for example at least any of 10%, 15%, 20%, or 25%) of carrier protein that is cross-linked.

In some embodiments, the average or mean diameter of the nanoparticles in the composition is no greater than about 200 nm. In some embodiments, the average or mean diameter of the particles is between about 20 nm to about 400 nm (such as about 40 nm to about 200 nm). In some embodiments, the nanoparticles are sterile-filterable. In some embodiments, the taxane in the nanoparticles is amorphous. In some embodiments, the nanoparticles are substantially free of polymeric core materials. In some embodiments, the nanoparticles comprise a core of taxane that is substantially free of polymeric materials (such as polymertic matrix). In some embodiments, the nanoparticles in the composition have a solid core. In some embodiments, the nanoparticles in the composition have a core that is not aqueous (i.e., other than aqueous core). In some embodiments, the nanoparticles of the composition are substantially free of lipids. In some embodiments, the nanoparticles of the composition are free of lipids.

In some embodiments, the composition comprises more than about 50% (for example more than about any of 60%, 70%, 80%, 90%, or 95%) of the taxane in nanoparticle form. In some embodiments, the weight percentage of the taxane in the nanoparticle portion of the taxane nanoparticle composition is at least about any of 50%, 60%, 70%, 80%, 90%, or 95% of the total weight of the nanoparticle portion of the composition.

In some embodiments, the composition is administered at least about any of once every three weeks, once every two weeks, once a week, twice a week, three times a week, four times a week, five times a week, six times a week, or daily. Other exemplary dosing frequencies include, but are not limited to, weekly, two out of three weeks; weekly, three out of four weeks; and weekly, four out of five weeks. In some embodiments, the composition is administered (with or without breaks in administration cycles) for at least about any of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more month(s).

In some embodiments, the composition is administered via any of intravenous, intraperitoneal, oral or inhalational routes. In some embodiments, the nanoparticle composition is administered with premedication. In some embodiments, the nanoparticle composition is administered without premedication.

The dose of the taxane in the nanoparticle composition will depend on the type of cancer to be treated, the severity and course of the cancer, the individual's clinical history, and the discretion of the attending physician. Suitable dosages of the taxane in the taxane nanoparticle compositions include, but are not limited to, about any of 50 mg/m2, 60 mg/m2, 75 mg/m2, 80 mg/m2, 90 mg/m2, 100 mg/m2, 120 mg/m2, 125 mg/m2, 150 mg/m2, 160 mg/m2, 180 mg/m2, 200 mg/m2, 210 mg/m2, 220 mg/m2, 230 mg/m2, 240 mg/m2, 260 mg/m2, and 300 mg/m2. Exemplary dosing schedules for the administration of the taxane nanoparticle composition (such as paclitaxel/albumin nanoparticle composition, for example Abraxane®) include, but are not limited to, 260 mg/m2, every three weeks; 60-150 mg/m2, weekly, without break, and 60-150 mg/m2, weekly, three out of four weeks. In addition, the taxane can be administered by following a metronomic dosing regime described herein. In some embodiments, the method comprises administering Abraxane® at 260 mg/m2 by 30 minutes IV infusion every three weeks.

Also provided herein are compositions, kits and unit dosage forms that are suitable for methods described herein. For example, in some embodiments, there is provided a composition for use in the treatment of a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), wherein the composition comprises nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a composition for use in decreasing one or more symptoms resulting from a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), wherein the composition comprises nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a composition for use in the treatment of a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer) in conjunction with a platinum-based agent, wherein the composition comprises nanoparticles comprising a taxane (such as paclitaxel), wherein the composition comprises nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a composition for use in decreasing one or more symptoms resulting from a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer) in conjunction with a platinum-based agent, wherein the composition comprises nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin).

These and other aspects and advantages of the present invention will become apparent from the subsequent detailed description and the appended claims. It is to be understood that one, some, or all of the properties of the various embodiments described herein may be combined to form other embodiments of the present invention.

BRIEF DESCRIPTION OF FIGURES

FIG. 1a shows overall survival among patients plotted in terms of months (x-axis) to proportion of survival (y-axis).

FIG. 1b shows progression free survival among patients plotted in terms of months (x-axis) to proportion not progressed (y-axis).

FIG. 2 shows a comparison of plasma level of paclitaxel when Nab-paclitaxel is administered intraperitoneally or intravenously (log-log).

FIG. 3 shows a comparison of plasma level of paclitaxel when Nab-paclitaxel is administered intraperitoneally or intravenously (log-linear).

DETAILED DESCRIPTION

OF THE INVENTION

The present invention provides methods for the treatment of a recurrent cancer (such as recurrent gynecological cancer) comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). Specifically, we have shown that a composition comprising nanoparticles comprising a taxane and a carrier protein (hereinafter designated as a “taxane nanoparticle composition”), particularly, a composition comprising nanoparticles comprising paclitaxel and albumin, more particularly, a composition comprising nanoparticles albumin bound paclitaxel (“Nab-paclitaxel”), was very active as a single agent or in combination with a platinum-based agent (carboplatin) in patients with platinum sensitive recurrent gynecological cancer, including recurrent ovarian, peritoneal, or fallopian tube cancer. The overall response rate for the treatment was 64% and the clinical benefit rate was 77%. Complete response was attained in about 70% patients treated with Abraxane® and carboplatin. This demonstrates that a taxane nanoparticle composition is particularly suitable (either as a single agent or in combination with a platinum-based agent) for treating platinum-sensitive recurrent cancer, particularly recurrent gynecological cancer.

Accordingly, the present invention in one aspect provides a method of treating a platinum-sensitive recurrent cancer comprising administering to the individual an effective amount of a composition (such as Nab-paclitaxel or Abraxane®) comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In another aspect, there is provided a method of treating a recurrent ovarian cancer (such as platinum-sensitive recurrent ovarian cancer) comprising administering to the individual an effective amount of a composition (such as Nab-paclitaxel or Abraxane®) comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin).

DEFINITIONS

As used herein, “the composition” or “compositions” includes and is applicable to compositions of the invention. The invention also provides pharmaceutical compositions comprising the components described herein.

Reference to “taxane” herein applies to a taxane or its derivatives and accordingly the invention contemplates and includes all these variations. Reference to “taxane” is to simplify the description and is exemplary. Taxanes include, but are not limited to, compounds that are structurally similar to or are in the same general chemical class such as paclitaxel (i.e., taxol), docetaxel (i.e., taxotere), or ortataxel, and pharmaceutically acceptable salts, derivatives, or analogs of paclitaxel, docetaxel, and ortataxel. Taxanes are antimicrobial agents that inhibit cell replication by promoting the assembly and stabilization of microtubule from tubulin dimers

Unless clearly indicated otherwise, “an individual” as used herein refers to human.

As used herein, “treatment” or “treating” is an approach for obtaining beneficial or desired results including clinical results. For purposes of this invention, beneficial or desired clinical results include, but are not limited to, one or more of the following: decreasing one or more symptoms resulting from the disease, diminishing the extent of the disease, stabilizing the disease (e.g., preventing or delaying the worsening of the disease), delay or slowing the progression of the disease, ameliorating the disease state, decreasing the dose of one or more other medications required to treat the disease, increasing the quality of life, and/or prolonging survival (including overall survival and progression free survival. In some embodiments, the composition reduces the severity of one or more symptoms associated with cancer by at least about any of 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 100% compared to the corresponding symptom in the same subject prior to treatment or compared to the corresponding symptom in other subjects not receiving the composition. Also encompassed by “treatment” is a reduction of pathological consequence of cancer. The methods of the invention contemplate any one or more of these aspects of treatment.

As used herein, “delaying” the development of cancer means to defer, hinder, slow, retard, stabilize, and/or postpone development of the disease. This delay can be of varying lengths of time, depending on the history of the disease and/or individual being treated. As is evident to one skilled in the art, a sufficient or significant delay can, in effect, encompass prevention, in that the individual does not develop the disease. A method that “delays” development of cancer is a method that reduces probability of disease development in a given time frame and/or reduces the extent of the disease in a given time frame, when compared to not using the method. Such comparisons are typically based on clinical studies, using a statistically significant number of subjects. Cancer development can be detectable using standard methods, such as routine physical exams or x-ray. Development may also refer to disease progression that may be initially undetectable and includes occurrence and onset.

“Adjuvant setting” refers to a clinical setting in which an individual has had a history of ovarian cancer, and generally (but not necessarily) been responsive to therapy, which includes, but is not limited to, surgery (e.g., surgical resection), radiotherapy, and chemotherapy. However, because of their history of the cancer, these individuals are considered at risk of development of the disease. Treatment or administration in the “adjuvant setting” refers to a subsequent mode of treatment. The degree of risk (i.e., when an individual in the adjuvant setting is considered as “high risk” or “low risk”) depends upon several factors, most usually the extent of disease when first treated.

“Neoadjuvant setting” refers to a clinical setting in which the method is be carried out before the primary/definitive therapy.

As used herein, an “at risk” individual is an individual who is at risk of developing cancer. An individual “at risk” may or may not have detectable disease, and may or may not have displayed detectable disease prior to the treatment methods described herein. “At risk” denotes that an individual has one or more so-called risk factors, which are measurable parameters that correlate with development of cancer, which are described herein. An individual having one or more of these risk factors has a higher probability of developing cancer than an individual without these risk factor(s).

As used herein, by “pharmaceutically active compound” is meant a chemical compound that induces a desired effect, e.g., treating, stabilizing, preventing, and/or delaying cancer.

As used herein, by “combination therapy” is meant a first therapy that includes nanoparticles comprising nanoparticles comprising a taxane (e.g. paclitaxel) and a carrier protein in conjunction with a second therapy (e.g., surgery or a therapeutic agent) useful for treating, stabilizing, preventing, and/or delaying cancer. Administration in “conjunction with” another compound includes administration in the same or different composition(s), either sequentially, simultaneously, or continuously. In some embodiments, the combination therapy optionally includes one or more pharmaceutically acceptable carriers or excipients, non-pharmaceutically active compounds, and/or inert substances.

The term “effective amount” refers to an amount of a drug effective to treat cancer in the patient. The effective amount of the drug may reduce the number of cancer cells; reduce the tumor size; inhibit (i.e., slow to some extent and preferably stop) cancer cell infiltration into peripheral organs; inhibit (i.e., slow to some extent and preferably stop) tumor metastasis; inhibit, to some extent, tumor growth; and/or relieve to some extent one or more of the symptoms associated with the cancer. To the extent the drug may prevent growth and/or kill existing cancer cells, it may be cytostatic and/or cytotoxic. The effective amount may extend progression free survival (e.g. as measured by Response Evaluation Criteria for Solid Tumors, RECIST, or CA-125 changes), result in an objective response (including a partial response or a complete response), increase overall survival time, and/or improve one or more symptoms of cancer (e.g. as assessed by FOSI).

As is understood in the art, an “effective amount” may be in one or more doses, i.e., a single dose or multiple doses may be required to achieve the desired treatment endpoint. An effective amount may be considered in the context of administering one or more therapeutic agents, and a nanoparticle composition (e.g., a composition including a taxane (e.g., paclitaxel) and a carrier protein) may be considered to be given in an effective amount if, in conjunction with one or more other agents, a desirable or beneficial result may be or is achieved.

In some embodiments, the amount of the composition is an amount sufficient to decrease the size of a tumor, decrease the number of cancer cells, or decrease the growth rate of a tumor by at least about any of 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95% or 100% compared to the corresponding tumor size, number of cancer cells, or tumor growth rate in the same subject prior to treatment or compared to the corresponding activity in other subjects not receiving the treatment. Standard methods can be used to measure the magnitude of this effect, such as in vitro assays with purified enzyme, cell-based assays, animal models, or human testing.

The term “proteins” refers to polypeptides or polymers of amino acids of any length (including full length or fragments), which may be linear or branched, comprise modified amino acids, and/or be interrupted by non-amino acids. The term also encompasses an amino acid polymer that has been modified naturally or by intervention, including, for example, disulfide bond formation, glycosylation, lipidation, acetylation, phosphorylation, or any other manipulation or modification. Also included within this term are, for example, polypeptides containing one or more analogs of an amino acid (including, for example, unnatural amino acids, etc.), as well as other modifications known in the art. The proteins described herein may be naturally-occurring, i.e., obtained or derived from a natural source (e.g., blood) or synthesized (e.g., chemically synthesized or by synthesized by recombinant DNA techniques). Exemplary carrier proteins are described herein.

The term “antimicrobial agent” used herein refers to an agent that is capable of inhibiting (e.g., delaying, reducing, slowing, and/or preventing) the growth of one or more microorganisms. Significant microbial growth can be measured or indicated by a number of ways known in the art, such as one or more of the following: (i) microbial growth in a composition that is enough to cause one or more adverse effects to an individual when the composition is administered to the individual; (ii) more than about 10-fold increase in microbial growth over a certain period of time (for example over a 24 hour period) upon extrinsic contamination (e.g., exposure to 10-103 colony forming units at a temperature in the range of 20 to 25° C.). Other indicia of significant microbial growth are described in U.S. Patent Application Publication No. US20070117744 (U.S. Ser. No. 11/514,030, filed Aug. 30, 2006), which is hereby incorporated by reference in its entirety.

“Sugar” as used herein includes, but is not limited to, monosaccharides, disaccharides, polysaccharides, and derivatives or modifications thereof. Suitable sugars for compositions described herein include, for example, mannitol, sucrose, fructose, lactose, maltose, and trehalose.

As used herein, by “pharmaceutically acceptable” or “pharmacologically compatible” is meant a material that is not biologically or otherwise undesirable, e.g., the material may be incorporated into a pharmaceutical composition administered to a patient without causing any significant undesirable biological effects or interacting in a deleterious manner with any of the other components of the composition in which it is contained. Pharmaceutically acceptable carriers or excipients have preferably met the required standards of toxicological and manufacturing testing and/or are included on the Inactive Ingredient Guide prepared by the U.S. Food and Drug administration.

“Survival” refers to the patient remaining alive, and includes overall survival as well as progression free survival.

“Overall survival” refers to the patient remaining alive for a defined period of time, such as 1 year, 5 years, etc. from the time of diagnosis or treatment.

“Progression free survival” refers to the patient remaining alive, without the cancer progressing or getting worse.

By “prolonging survival” is meant increasing overall or progression free survival in a treated patient relative to an untreated patient (e.g. relative to a patient not treated with a taxane nanoparticle composition).

As used herein, reference to “not” a value or parameter generally means and describes “other than” a value or parameter. For example, if a taxane is not administered, it means an agent other than a taxane is administered.

Reference to “about” a value or parameter herein includes (and describes) variations that are directed to that value or parameter per se. For example, description referring to “about X” includes description of “X”.’

As used herein and in the appended claims, the singular forms “a,” “or,” and “the” include plural referents unless the context clearly dictates otherwise. It is understood that aspects and variations of the invention described herein include “consisting” and/or “consisting essentially of” aspects and variations.

Methods of the Present Invention

The present invention provides methods for the treatment of a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) by administering a composition comprising nanoparticles comprising a taxane and a carrier protein. In some embodiments, there is provided a method of treating a recurrent cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein. In some embodiments, the recurrent cancer is platinum sensitive. In some embodiments, the recurrent cancer is platinum resistant. In some embodiments, the recurrent cancer is any of recurrent ovarian cancer, recurrent peritoneal cancer, recurrent fallopian tube cancer, recurrent malignant mixed mullerian tumor, and serous endo.

In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein. In some embodiments, there is provided a method of treating a platinum-sensitive recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein. In some embodiments, the recurrent cancer is a recurrent ovarian cancer (such as a recurrent epithelial ovarian cancer). In some embodiments, the recurrent cancer is a recurrent peritoneal cancer. In some embodiments, the recurrent cancer is a recurrent fallopian tube cancer (including for example papillary serous adenocarcinomas, sarcomas, and transitional cell carcinomas).

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received a prior chemotherapy and has a treatment free interval for more about any of 3, 6, 9 months since the completion of prior chemotherapy. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received a prior chemotherapy and has a treatment free interval for more about any of 12, 18, 24, 36, or 48 months since the completion of prior chemotherapy. In some embodiments, the prior chemotherapy has a different mechanism of action than that of the taxane-based therapy. In some embodiments, the individual has only been treated with platinum-based agent(s) prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has only been treated with one dosing regime prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has not previously been treated with a taxane-based therapy.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received prior platinum-based chemotherapy and has a treatment free interval for more than about any of 3, 6, 9 months since the completion of the platinum-based chemotherapy. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received prior platinum-based chemotherapy and has a treatment free interval for more than about any of 12, 18, 24, 36, or 38 months since the completion of the platinum-based chemotherapy. In some embodiments, the method further comprises administering to the individual an effective amount of a platinum-based agent (such as carboplatin). In some embodiments, the composition comprising nanoparticles comprising a taxane and a carrier protein is not administered in conjunction with a platinum agent, that is, the composition comprising nanoparticles comprising a taxane and a carrier protein is either administered alone or administered in conjunction with a chemotherapeutic agent other than a platinum-based agent.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received a prior chemotherapy and has a treatment free interval for more about any of 3, 6, 9 months prior to the initiation of the treatment method with the taxane nanoparticle composition. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received a prior chemotherapy and has a treatment free interval for more about any of 12, 18, 24, 36, or 48 months prior to the initiation of the treatment method with the taxane nanoparticle composition. In some embodiments, the prior chemotherapy has a different mechanism of action than that of the taxane-based therapy. In some embodiments, the individual has only been treated with platinum-based agent(s) prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has only been treated with one dosing regime prior to the administration of the taxane nanoparticle composition. In some embodiments, the individual has not previously been treated with a taxane-based therapy.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received prior platinum-based chemotherapy and has a treatment free interval for more than about any of 3, 6, 9 months prior to the initiation of the treatment method with the taxane nanoparticle composition. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual has received prior platinum-based chemotherapy and has a treatment free interval for more than about any of 12, 18, 24, 36, or 38 months prior to the initiation of the treatment method with the taxane nanoparticle composition. In some embodiments, the method further comprises administering to the individual an effective amount of a platinum-based agent. In some embodiments, the composition comprising nanoparticles comprising a taxane and a carrier protein is not administered in conjunction with a platinum agent, that is, the composition comprising nanoparticles comprising a taxane and a carrier protein is either administered alone or administered in conjunction with a chemotherapeutic agent other than a platinum-based agent.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual does not show a symptom of hypersensitivity (such as neuropathy) prior to the initiation of the treatment method with the taxane nanoparticle composition. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual does not show a symptom of hypersensitivity throughout the treatment period. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the individual does not show symptoms of hypersensitivity upon completion of the treatment.

In some embodiments, the composition comprising nanoparticles comprising a taxane and a carrier protein is administered alone. For example, in some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the amount of the composition administered to the individual alone is effective to result in a complete response in the individual. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the amount of the composition administered to the individual alone is effective to result in a partial response in the individual.

In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the amount of the composition administered to the individual alone is sufficient to produce an overall response rate of more than about any of 40%, 50%, 60%, or 64% among a population of individuals treated with the composition. In some embodiments, there is provided a method of treating a recurrent cancer (such as a recurrent gynecological cancer for example recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the amount of the composition administered to the individual alone is sufficient to produce clinical benefit of more than about any of 50%, 60%, 70%, or 77% among a population of individuals treated with the composition.

In some embodiments, the method comprises administering to the individual an effective amount of a composition comprising nanoparticles comprising paclitaxel and albumin. In some embodiments, the method comprises administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein average or mean diameter of the nanoparticles in the composition is less than about 200 nm. In some embodiments, the method comprises administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the nanoparticles comprise taxane coated with a coating comprising the carrier protein. In some embodiments, the method comprises administering to the individual an effective amount of a Nab-paclitaxel (such as Abraxane®). For example, in some embodiments, there is provided a method of treating a platinum-sensitive recurrent ovarian, peritoneal, or fallopian tube cancer in the individual, comprising administering to the individual an effective amount of Nab-paclitaxel or Abraxane®.

In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer (such as a platinum-resistant ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual about 50 mg/m2 to about 300 mg/m2 (including for example about 260 mg/m2) Nab-paclitaxel or Abraxane®. In some embodiments, the Nab-paclitaxel or Abraxane® is administered every three weeks. In some embodiments, the Nab-paclitaxel or Abraxane® is administered intravenously (such as by i.v. infusion over a period of about 30 minutes or less). In some embodiments, the Nab-paclitaxel or Abraxane® is administered intraperitoneally.

The methods of the present invention are useful for any one or more of the following (and thus in various embodiments can achieve and/or include any one or more of the following): 1) decreasing one or more symptoms resulting from recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); 2) increasing overall response rate of a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); 3) increasing partial response rate of a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); 4) increasing complete response rate of a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); 5) delaying disease progression of an individual with a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); 6) increasing the quality of life in an individual with recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); 7) prolonging overall survival of an individual having recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer); and 8) prolonging progression-free survival of an individual having recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer).

Accordingly, in some embodiments, there is provided a method of decreasing one or more symptoms resulting from a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a method of decreasing one more symptoms resulting from a recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of Nab-paclitaxel or Abraxane®.

In some embodiments, there is provided a method of increasing response rate of recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a method of increasing response rate of recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of Nab-paclitaxel or Abraxane®.

In some embodiments, there is provided a method of delaying disease progression of an individual with recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a method of delaying disease progression of an individual with recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of Nab-paclitaxel or Abraxane®.

In some embodiments, there is provided a method of prolonging survival of an individual having recurrent cancer (such as recurrent gynecological cancer for example recurrent ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin). In some embodiments, there is provided a method of prolonging survival of an individual having recurrent cancer (such as recurrent gynecological cancer for example ovarian, peritoneal, and fallopian tube cancer), comprising administering to the individual an effective amount of Nab-paclitaxel or Abraxane®.

In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein one or more symptoms resulting from the recurrent cancer is decreased. In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein the individual has a partial response to treatment upon completion of less than about any of one, two, three, four, five, six, seven, or eight treatment cycles. In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein the individual has a complete response to treatment upon completion of less than about any of one, two, three, four, five, six, seven, or eight treatment cycles. In some embodiments, the treatment cycle is four weeks. In some embodiments, the treatment cycle is three weeks.

In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein the individual is disease free for at least about any of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, or 24 months upon completion of the treatment. In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein the individual does not show a symptom resulting from the recurrent cancer for at least about any of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, or 24 months upon completion of the treatment. In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering to the individual an effective amount of a composition comprising nanoparticles comprising a taxane and a carrier protein, wherein the individual has a reduced CA-125 level (such as a level below about any of 70%, 60%, 50%, 40%, 30%, 20%, 10% of the level prior to the treatment) upon completion of the treatment. In some embodiments, the individual has a reduced CA-125 level for at least about any of 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, or 24 months upon completion of the treatment.

In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering (for example intravenously or intraperitoneally) to the individual an effective amount of a composition comprising nanoparticles comprising a taxane (such as paclitaxel) and a carrier protein (such as albumin), wherein the amount of the taxane per administration is at least about 50 mg/m2 (such as at least about any of 70 mg/m2, 100 m g/m2, 150 mg/m2, 200 mg/m2, or 260 mg/m2), and wherein one or more symptoms resulting from the recurrent cancer is decreased. In some embodiments, there is provided a method of treating a recurrent ovarian, peritoneal, or fallopian tube cancer in an individual, comprising administering (for example intravenously or intraperitoneally) to the individual an effective amount of Abraxane®, wherein the amount of paclitaxel per administration is at least about 50 mg/m2 (such as at least about any of 70 mg/m2, 100 mg/m2, 150 mg/m2, 200 mg/m2, or 260 mg/m2), and wherein one or more symptoms resulting from the recurrent cancer is decreased. In some embodiments, the composition is administered once every three weeks. In some embodiments, the composition is administered weekly. In some embodiments, the composition is administered three out of four weeks. In some embodiments, the individual does not show a symptom of hypersensitivity (such as neuropathy) prior to the initiation of the treatment. In some embodiments, the individual does not show a symptom of hypersensitivity throughout the treatment period. In some embodiments, the individual does not show a symptom of hypersensitivity upon completion of the treatment.

In some embodiments, the taxane nanoparticle composition is administered in conjunction with another chemotherapeutic agent (such as a platinum-based agent). For example, in some embodiments, the taxane nanoparticle composition and the other chemotherapeutic agent (such as a platinum-based agent) are administered simultaneously. The term “simultaneous administration,” as used herein, means that the taxane nanoparticle composition and the other chemotherapeutic agent are administered with a time separation of no more than about 15 minute(s), such as no more than about any of 10, 5, or 1 minutes. When the drugs are administered simultaneously, the taxane in the nanoparticles and the other chemotherapeutic agent may be contained in the same composition (e.g., a composition comprising both the nanoparticles and the other chemotherapeutic agent) or in separate compositions (e.g., the nanoparticles are contained in one composition and the other chemotherapeutic agent is contained in another composition). For example, the taxane and the other chemotherapeutic agent may be present in a single composition containing at least two different nanoparticles, wherein some of the nanoparticles in the composition comprise the taxane and a carrier protein, and some of the other nanoparticles in the composition comprise the other chemotherapeutic agent and a carrier protein. In some embodiments, only the taxane is contained in nanoparticles. In some embodiments, simultaneous administration of the drug in the nanoparticle composition and the other chemotherapeutic agent can be combined with supplemental doses of the taxane and/or the other chemotherapeutic agent.



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stats Patent Info
Application #
US 20140017316 A1
Publish Date
01/16/2014
Document #
13781482
File Date
02/28/2013
USPTO Class
424489
Other USPTO Classes
514449
International Class
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Nanoparticle
Fallopian Tube
Fallopian Tube Cancer
Ovarian
Paclitaxel
Peritoneal
Recur
Recurrent
Taxane


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