Gemcitabine and Cisplatin in Treating Patients With Refractory 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and cisplatin in treating patients who have refractory or recurrent cancer of the cervix.

Detailed Description
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OBJECTIVES: Determine the antitumor activity of gemcitabine and cisplatin in patients with refractory or recurrent squamous cell carcinoma of the cervix. Determine the nature and degree of toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive cisplatin IV and gemcitabine IV over 1 hour on days 1 and 8. Treatment continues every 28 days 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: A total of 28-69 patients will be accrued for this study.

Official Title
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A Phase II Evaluation Of Gemcitabine And Cisplatin In Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: cisplatin
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapy and is considered incurable Must have had 1 prior chemotherapy regimen for cervical cancer No more than 1 prior chemotherapy regimen (single or combination drug therapy), unless used as a radiosensitizer No prior chemotherapy for recurrent or persistent disease including retreatment with initial chemotherapy Bidimensionally measurable disease Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Platelet count at least lower limit of normal Absolute neutrophil 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 2.0 mg/dL Other: Not pregnant Fertile patients must use effective contraception No significant infection No other malignancies within past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy for cervical cancer Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy for cervical cancer and recovered No prior gemcitabine Endocrine therapy: At least 3 weeks since prior endocrine therapy for cervical cancer Radiotherapy: At least 3 weeks since prior radiotherapy for cervical cancer and recovered No prior radiotherapy to more than 25% of marrow-bearing areas Surgery: At least 3 weeks since prior surgery for cervical cancer and recovered Other: No concurrent amifostine or other protective reagents No prior anticancer therapy that contraindicates study
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: cisplatin|nan|
|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, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma