A Phase II Evaluation of Ixabepilone (BMS-247550) [NCI-Supplied Agent, IND #59699, NSC #710428]) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
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 ≤ 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