Ovarian Cancer, Peritoneal Cavity Cancer
Conditions
Keywords
stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, peritoneal cavity cancer
Brief summary
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
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinical remission | up to 12-months post-treatment | number of participants experience clinical remission will be determined |
Countries
United States