Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney 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: This phase II trial is studying how well gemcitabine and cisplatin work in treating patients with metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin. Assess toxicity of this regimen in these patients. OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months. PROJECTED ACCRUAL: Approximately 29-38 patients will be accrued for this study.

Official Title
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A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma

Conditions
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Kidney 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 proven metastatic renal cell carcinoma No brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm^3 Hematocrit at least 30% Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL AST and ALT no greater than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncontrolled hypertension No myocardial infarction within the past 8 weeks Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of cervix, prostate intraepithelial neoplasia, or superficial bladder cancer No significant psychiatric disease No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: No more than 2 prior biologic response modifier regimens No concurrent biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed if measurable disease is outside radiation port At least 28 days since prior radiotherapy No concurrent radiotherapy Surgery: Prior surgery allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|Cisplatin IV over 60 minutes on day 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.|
|Drug: gemcitabine hydrochloride|Gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin. |  | Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer