Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and amifostine following surgery in treating patients who have locally advanced bladder cancer.
Drug/Agent Toxicity by Tissue/Organ
Drug: amifostine trihydrate
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer|
- Side effects of cisplatin/gemcitabine in combination with amifostine [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2000|
|Study Completion Date:||September 2006|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
Experimental: Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
|Drug: amifostine trihydrate Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy|
- Determine the toxicity of adjuvant gemcitabine and cisplatin with amifostine cytoprotection in patients with completely resected locally advanced bladder cancer.
- Compare recurrence rate in these patients when treated with this regimen to historical control patients who had a cystectomy performed by the same surgeon.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, and cisplatin IV over 60 minutes and amifostine IV over 15 minutes on day 1. Treatment continues every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006105
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|Study Chair:||Walter M. Stadler, MD, FACP||University of Chicago|