A Phase II Evaluation Of Pemetrexed (ALIMTA, LY231517, IND #40061) In the Treatment Of Recurrent Carcinoma Of The Cervix

Date de début de l'étude : 1 août 2004

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