Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have advanced, persistent, or recurrent cervical cancer.

Detailed Description
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OBJECTIVES: Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. Determine the toxicity profile of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

Official Title
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A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: capecitabine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix Documented disease progression after local therapy and considered incurable At least 1 target lesion measurable in at least 1 dimension At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan Target lesion cannot be in a previously irradiated field PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine clearance at least 50 mL/min Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No neuropathy (sensory and motor) greater than grade I PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: At least 3 weeks since prior chemotherapy for the malignant tumor and recovered No prior cytotoxic therapy (except when used as a radiosensitizer) No prior chemotherapy for other malignancy 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 3 weeks since prior radiotherapy for the malignant tumor and recovered No prior radiotherapy for other malignancy Surgery: Recovered from prior surgery Other: At least 3 weeks since any other prior therapy for the malignant tumor No prior anticancer therapy that contraindicates study therapy No concurrent amifostine or other protective reagents
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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

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