Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer

PRIMARY OBJECTIVES:

I. Determine the response rate in patients with recurrent or persistent endometrial adenocarcinoma treated with ixabepilone.

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

OUTLINE: This is a multicenter study.

Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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 2.5 years.

Inclusion criteria

• Histologically confirmed endometrial adenocarcinoma

• Recurrent or persistent disease

• Histologic confirmation of the original primary tumor is required
• Not amenable to management with any of the following:

• Surgery
• Radiotherapy
• Higher priority or standard chemotherapy
• Measurable disease

• At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
• At least 1 target lesion

• Tumors within a previously irradiated field are designated as non-target lesions
• Disease in an irradiated field as the only site of measurable disease is acceptable as a target lesion only if there has been clear progression of the lesion at least 90 days after completion of radiotherapy
• Received 1, and only 1, prior chemotherapy regimen (e.g., high-dose therapy, consolidation, or extended therapy administered after surgery or non-surgical assessment) for management of endometrial adenocarcinoma
• Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (e.g., any active GOG phase III study for the same patient population)
• 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)
• AST (aspartate aminotransferase) ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN
• Sensory or motor neuropathy ≤ grade 1
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection requiring antibiotics
• No other invasive malignancies within the past 5 years except non-melanoma skin cancer
• At least 3 weeks since prior biologic or immunologic agents directed at the malignant tumor
• One prior non-cytotoxic* (biologic or cytostatic) regimen for management of recurrent or persistent disease allowed
• See Disease Characteristics
• Prior paclitaxel or docetaxel allowed
• Recovered from prior chemotherapy
• No more than 1 prior cytotoxic chemotherapy regimen (either single or combination drug therapy)
• No prior ixabepilone
• At least 1 week since prior hormonal therapy directed at the malignant tumor

• Continuation of hormone replacement therapy allowed
• See Disease Characteristics
• Recovered from prior radiotherapy
• Recovered from prior surgery
• At least 3 weeks since other prior therapy directed at the malignant tumor
• No prior cancer treatment that contraindicates study therapy