NCT00003928

Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1999-01-01
• Primary completion: 2005-02-01
• Completion: 2006-04-01
• First posted: 2003-01-27
• Last updated: 2010-06-11

Locations

1 site across 1 country: United States