Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer.

Detailed Description
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OBJECTIVES: Primary Determine the antitumor activity of ixabepilone, in terms of clinical response and progression-free survival, in patients with relapsed and/or refractory stage III or IV ovarian epithelial or primary peritoneal cancer. Determine the nature and degree of toxicity of this drug in these patients. Secondary Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response (i.e., at least partial response vs no response). Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms with parent drug kinetic parameters, toxicity, and efficacy of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.

Official Title
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Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy

Conditions
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Ovarian Cancer, Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: ixabepilone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal carcinoma Recurrent or refractory disease Previously treated with 1, and only 1, prior chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound and paclitaxel or docetaxel Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment Bidimensionally measurable disease by physical exam, CT scan, or MRI Ascites and pleural effusions are not measurable disease No prior irradiation to indicator lesions PATIENT CHARACTERISTICS: Age 18 to 75 Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No prior bleeding disorder or unexplained bleeding Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 times ULN Other No active infection requiring antibiotics No grade 2 or greater neuropathy (sensory and motor) No other malignancy within the past 5 years except nonmelanoma skin cancer No prior recurrent grade 2 or greater hypersensitivity reactions to Cremophor EL, docetaxel, or paclitaxel No other medical condition that would preclude study participation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior biologic or immunologic therapy for ovarian epithelial or primary peritoneal carcinoma Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior ixabepilone No prior cytotoxic chemotherapy (including retreatment with initial chemotherapy regimens) for recurrent or persistent ovarian epithelial or primary peritoneal carcinoma Endocrine therapy At least 1 week since prior hormonal therapy for ovarian epithelial or primary peritoneal carcinoma Concurrent hormonal replacement therapy allowed Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to a site of measurable disease used on study No prior radiotherapy to more than 25% of bone marrow Surgery See Disease Characteristics Recovered from prior surgery Other At least 3 weeks since other prior therapies for ovarian epithelial or primary peritoneal carcinoma No prior cancer treatment for other invasive malignancies that would preclude study participation No concurrent heparin or other anticoagulants No concurrent Hypericum perforatum (St. John's wort) or any product containing this compound

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ixabepilone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical remission | number of participants experience clinical remission will be determined | up to 12-months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer