Pemetrexed Disodium in Treating Patients With Recurrent Cancer of the Cervix

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: pemetrexed disodium


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: pemetrexed disodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor activity |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical squamous cell carcinoma, recurrent cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer