Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma, Stage IV Endometrial Carcinoma
About this trial
This is an interventional treatment trial for Endometrial Adenocarcinoma
Eligibility Criteria
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
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.