• Frequency and duration of objective response [ Designated as safety issue: No ]
  
• Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]
  
• Survival time [ Designated as safety issue: No ]
  
• Duration of progression-free survival [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer.
• Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: Patients receive ixabepilone IV over 1 hour. Treatment repeats every 21 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.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 6-12 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer

  • Recurrent or persistent disease

  • Platinum AND taxane-resistant or refractory disease

    • Progressed during therapy OR
    • 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 protocol
• No active brain metastases

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN

Renal:

• Creatinine ≤ 1.5 times ULN

Neurologic:

• No sensory or motor neuropathy > grade 1
• No dementia or altered mental status

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy
• At least 3 weeks since prior immunotherapy

Chemotherapy:

• See Disease Characteristics

• Must have received:

  • 1 prior combination taxane-based and platinum-based chemotherapy regimen OR
  • 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

Endocrine therapy:

• At least 1 week since prior hormonal anticancer therapy
• Concurrent hormone replacement therapy allowed

Radiotherapy:

• 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

Surgery:

• Recovered from recent surgery

Other:

• 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