Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

PRIMARY OBJECTIVES:

I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.

II. Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE:

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.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

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