Gemcitabine Plus Cisplatin in Treating Patients With Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00003928|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 11, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: cisplatin Drug: gemcitabine hydrochloride||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Utilizing Gemcitabine and Cisplatinum in Patients With Renal Cell Carcinoma|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||February 2005|
|Actual Study Completion Date :||April 2006|
- 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|