NCT00006105

Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Chicago · 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. 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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Bladder Cancer
• Drug/Agent Toxicity by Tissue/Organ

Interventions

Type	Name	Description
DRUG	amifostine trihydrate
DRUG	cisplatin
DRUG	gemcitabine hydrochloride
PROCEDURE	adjuvant therapy

Timeline

• Start date: 2000-06-01
• Primary completion: 2004-11-01
• Completion: 2006-09-01
• First posted: 2003-01-27
• Last updated: 2013-09-05

Locations

1 site across 1 country: United States