Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer Recurrent or persistent disease Platinum AND taxane-resistant or refractory disease Progressed during therapy Refractory disease within 6 months of therapy Measurable disease At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol No active brain metastases Performance status - GOG 0-2 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Bilirubin ≤ 1.5 times upper limit of normal (ULN) SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Creatinine ≤ 1.5 times ULN No sensory or motor neuropathy > grade 1 No dementia or altered mental status No other serious uncontrolled medical disorder No active infection requiring antibiotics No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL No other malignancy within the past 5 years except nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 3 weeks since prior biologic therapy At least 3 weeks since prior immunotherapy Must have received: 1 prior combination taxane-based and platinum-based chemotherapy regimen 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen Initial treatment may include high-dose therapy, consolidation, or extended therapy At least 3 weeks since prior chemotherapy and recovered No prior ixabepilone No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen At least 1 week since prior hormonal anticancer therapy Concurrent hormone replacement therapy allowed At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to site(s) of measurable disease No radiotherapy to > 25% of marrow-containing areas Recovered from recent surgery At least 3 weeks since other anticancer therapy No prior anticancer therapy that precludes study participation No concurrent food supplements (e.g., St. John's wort) No concurrent amifostine or other protective agents
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (ixabepilone)
Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.