Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma|
- 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. ] [ Designated as safety issue: No ]
|Study Start Date:||January 1999|
|Study Completion Date:||April 2006|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003928
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|