Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

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 gemcitabine in treating patients who have persistent or recurrent cancer of the cervix.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: Approximately 15-37 patients will be accrued for this study within 1 year.

Official Title
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Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable Eligible subtypes: Adenocarcinoma Adenosquamous carcinoma Undifferentiated carcinoma Must have documented disease progression Histologic confirmation of original primary tumor required Bidimensionally measurable disease Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm^3 Granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection Not pregnant Fertile patients must use effective contraception No other invasive malignancy within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) Chemotherapy: No prior gemcitabine At least 3 weeks since other prior chemotherapy for cervical cancer and recovered No more than 1 prior chemotherapy regimen (single or combination cytotoxic therapy) Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy for cervical cancer and recovered Surgery: At least 3 weeks since prior surgery for cervical cancer and recovered Other: No prior cancer treatment that would preclude study

Ages Eligible for Study
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Minimum Age: 18 Years

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: gemcitabine hydrochloride|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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recurrent cervical cancer, cervical adenocarcinoma, cervical adenosquamous cell carcinoma