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Methods and compositions for treating recurrent cancer

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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.



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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
/
Drawings
3


Nanoparticle
Fallopian Tube
Fallopian Tube Cancer
Ovarian
Paclitaxel
Peritoneal
Recur
Recurrent
Taxane


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