Gemcitabine in Treating Patients With Recurrent or Persistent Endometrial Cancer

Inclusion Criteria

• Histologically confirmed endometrial adenocarcinoma
• Recurrent or persistent disease
• Refractory to curative therapy or established treatments
• The following epithelial cell types are eligible:
• Endometrioid adenocarcinoma
• Serous adenocarcinoma
• Undifferentiated carcinoma
• Clear cell adenocarcinoma
• Mixed epithelial carcinoma
• Adenocarcinoma not otherwise specified
• Mucinous adenocarcinoma
• Squamous cell carcinoma
• Transitional cell carcinoma
• Mesonephric carcinoma
• Measurable disease, defined as ≥1 lesion that can be accurately measured in ≥ 1 dimension as ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR as ≥ 10 mm by spiral CT scan
• Must have ≥ 1 target lesion
• Tumors within a previously irradiated field are designated as target lesions provided there is documented disease progression or biopsy confirmed persistent disease ≥ 90 days after completion of radiotherapy
• Must have received 1 prior chemotherapeutic regimen for management of endometrial cancer
• Initial treatment may have included non-cytotoxic agents or high-dose therapy, consolidation therapy, or extended therapy administered after surgical or non-surgical assessment
• No more than one prior cytotoxic chemotherapy regimen (either with single or combination cytotoxic drug therapy)
• One additional non-cytotoxic regimen for management of recurrent or persistent disease is allowed
• Not eligible for a higher priority GOG protocol, if one exists (i.e., any active Phase III GOG protocol for the same patient population)
• GOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• No neuropathy (sensory and motor) > grade 1, according to NCI CTCAE v3.0
• No active infection requiring antibiotics (except an uncomplicated urinary tract infection)
• No other invasive malignancies within the past 5 years except non-melanoma skin cancer
• No prior cancer treatment that contraindicates study therapy
• Recovered from prior surgery, radiotherapy, or chemotherapy
• At least 1 week since prior hormonal therapy for endometrial cancer
• At least 3 weeks since prior biological therapy, immunotherapy, or other therapy for endometrial cancer
• At least 4 weeks since prior radiotherapy
• More than 3 years since prior radiotherapy for localized breast cancer, head and neck cancer, or skin cancer and
• No recurrent or persistent breast cancer, head and neck cancer, or skin cancer
• More than 3 years since prior adjuvant chemotherapy for localized breast cancer
• No recurrent or metastatic breast cancer
• No prior radiotherapy to any portion of the abdominal cavity or pelvis except for the treatment of endometrial cancer
• No prior chemotherapy for any abdominal or pelvic tumor except for the treatment of endometrial cancer
• No prior gemcitabine hydrochloride