Spots Global Cancer Trial Database for Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT00006105

Conditions

Bladder Cancer

Drug/Agent Toxicity by Tissue/Organ

Interventions

amifostine trihydrate

cisplatin

gemcitabine hydrochloride

adjuvant therapy

Study Description

Brief 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.