Status:
COMPLETED
Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Gynecologic Oncology Group
Conditions:
Endometrial Adenocarcinoma
Recurrent Endometrial Carcinoma
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. This phase II trial is studying how well ixabepilone works in tre...
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00095979
Start Date
May 1 2005
End Date
July 1 2009
Last Update
July 24 2019
Active Locations (1)
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1
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103