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

Phase 2

Completed

• Conditions: Bladder Cancer; Drug/Agent Toxicity by Tissue/Organ
• Interventions: Drug: amifostine trihydrate; Drug: cisplatin; Drug: gemcitabine hydrochloride; Procedure: adjuvant therapy

• Registration Number: NCT00006105
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study Start: 2000-06
• Study First Submitted: 2000-08-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-11
• Study Completion: 2006-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Cisplatin, Gemcitabine, and Amifostine	gemcitabine hydrochloride	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.
Administration of Cisplatin, Gemcitabine, and Amifostine	amifostine trihydrate	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.
Administration of Cisplatin, Gemcitabine, and Amifostine	adjuvant therapy	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.
Administration of Cisplatin, Gemcitabine, and Amifostine	cisplatin	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.

Primary Outcome Measures

Name	Time	Method
Side effects of cisplatin/gemcitabine in combination with amifostine	4 months

Trial Locations

Locations (1)

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States