Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Ovarian Cancer, Peritoneal Cavity Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer
Eligibility Criteria
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
Sites / Locations
- Albert Einstein Cancer Center at Albert Einstein College of Medicine