Pemetrexed Disodium in Treating Patients With Persistent or Recurrent Endometrial Cancer
Endometrial Cancer
About this trial
This is an interventional treatment trial for Endometrial Cancer focused on measuring recurrent endometrial carcinoma, endometrial adenocarcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed endometrial adenocarcinoma Persistent or recurrent disease Refractory to curative or standard therapy Measurable disease At least 1 unidimensionally measurable target lesion ≥ 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by spiral CT scan Tumors within a previously irradiated field are considered non-target lesions unless progression is documented or biopsy is obtained to confirm persistence ≥ 90 days after completion of radiotherapy Must have received 1 prior chemotherapy regimen for endometrial cancer Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population) PATIENT CHARACTERISTICS: Age Any age Performance status GOG 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9 g/dL Hepatic AST and ALT ≤ 3 times upper limit of normal (ULN)* Alkaline phosphatase ≤ 3 times ULN* Bilirubin ≤ 1.5 times ULN NOTE: * ≤ 5 times ULN if liver metastases are present Renal Creatinine clearance ≥ 45 mL/min Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study participation Neuropathy (sensory and motor) ≤ grade 1 No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 weeks since prior biologic or immunologic agents for the malignant tumor One prior non-cytotoxic (biologic or cytostatic) regimen for recurrent or persistent disease allowed, including, but not limited to, the following: Monoclonal antibodies Cytokines Small-molecule inhibitors of signal transduction At least 24 hours since prior growth factors No concurrent routine colony-stimulating factors Chemotherapy See Disease Characteristics Recovered from prior chemotherapy No more than 1 prior cytotoxic chemotherapy regimen with either single or combination cytotoxic drug therapy No prior pemetrexed disodium Endocrine therapy At least 1 week since prior hormonal therapy directed at the malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered No prior radiotherapy to ≥ 25% of bone marrow Surgery Recovered from prior surgery Other At least 3 weeks since other prior therapy directed at the malignant tumor No nonsteroidal anti-inflammatory drugs 2-5 days before, during, and for 1-2 days after study drug administration Concurrent daily low-dose (≤ 325 mg/day) aspirin therapy allowed No prior therapy that would contraindicate study participation
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA
- Hinsdale Hematology Oncology Associates
- CCOP - Carle Cancer Center
- St. Vincent Indianapolis Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Massachusetts General Hospital
- West Michigan Cancer Center
- University of Mississippi Cancer Clinic
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- SUNY Downstate Medical Center
- Alamance Cancer Center at Alamance Regional Medical Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Riverside Methodist Hospital Cancer Care
- David L. Rike Cancer Center at Miami Valley Hospital
- Lake/University Ireland Cancer Center
- Oklahoma University Cancer Institute
- Cancer Care Associates - Midtown Tulsa
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Avera Cancer Institute
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas