pemetrexed disodium in treating patients with recurrent cancer of the cervix

Conditions: Cervical Cancer

Summary: rationale: drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die. purpose: this phase ii trial is studying how well pemetrexed disodium works in treating patients with recurrent cancer of the cervix.

objectives: * determine the antitumor activity of pemetrexed disodium in patients with recurrent carcinoma of the cervix that failed higher priority treatment protocols. * determine the nature and degree of toxicity of this drug in these patients. outline: this is a multicenter study. patients receive pemetrexed disodium iv over 10 minutes on day 1. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin b_12) intramuscularly every 9 weeks. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: approximately 22-60 patients will be accrued for this study within 1-2 years.

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

Keywords: cervical squamous cell carcinoma recurrent cervical cancer stage iii cervical cancer stage iva cervical cancer stage ivb cervical cancer