A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Kidney Cancer
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assess the response rate of patients with metastatic renal cell carcinoma treated with gemcitabine and cisplatin.
Time Frame: Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.