Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix
Cervical Cancer
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed carcinoma of the cervix Squamous cell or non-squamous cell Recurrent disease Progressive disease 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 disease progression is documented or a biopsy is obtained to confirm persistence at least 90 days after completion of radiotherapy Not amenable to surgery, radiotherapy, or other therapy Must have received 1 prior systemic chemotherapy regimen for persistent or recurrent squamous cell or non-squamous cell carcinoma of the cervix Chemotherapy administered with primary radiotherapy as a radiosensitizer is not considered a systemic chemotherapy regimen 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 At least 24 hours since prior growth factors 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 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 for 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 for the malignant tumor No nonsteroidal anti-inflammatory drugs for 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
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Doctors Medical Center
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Hinsdale Hematology Oncology Associates
- CCOP - Kansas City
- St. John's Regional Health Center
- Women's Cancer Center - Las Vegas
- SUNY Downstate Medical Center
- SUNY Upstate Medical University Hospital
- Hope A Women's Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Case Comprehensive Cancer Center
- MetroHealth's Cancer Care Center at MetroHealth Medical Center
- Hillcrest Cancer Center at Hillcrest Hospital
- Oklahoma University Medical Center
- Cancer Care Associates - Midtown Tulsa
- Williamette Gynecologic Oncology P.C.
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- M.D. Anderson Cancer Center at University of Texas
- Massey Cancer Center at Virginia Commonwealth University