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Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer

Phase 2
Completed
Conditions
Kidney Cancer
Registration Number
NCT00003928
Lead Sponsor
Case Comprehensive Cancer Center
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

🇺🇸

Cleveland, Ohio, United States

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