Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Closed	18 and over	NCI	UCCRC-9193 UCCRC-CTRC-9806, NCI-G00-1831, NCT00006105

Objectives

1. Determine the toxicity of adjuvant gemcitabine and cisplatin with amifostine cytoprotection in patients with completely resected locally advanced bladder cancer.
2. Compare recurrence rate in these patients when treated with this regimen to historical control patients who had a cystectomy performed by the same surgeon.

Entry Criteria

Disease Characteristics:

• Completely resected locally advanced bladder cancer
  • T2-4, N0-2



• Post radical cystectomy with no gross residual disease



• No evidence of metastases by CT of chest, abdomen, and pelvis

Prior/Concurrent Therapy:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent hormonal therapy except contraceptives and replacement steroids

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 4 but no more than 8 weeks since radical cystectomy

Other:

• No other concurrent experimental medications

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9.0 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST and ALT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

  OR

• Creatinine clearance at least 50 mL/min

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 3 months after study participation
• No active infection
• No serious concurrent systemic disorders that would preclude study participation
• No metastatic cancer in past 5 years

Expected Enrollment

A total of 19-42 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Walter Stadler, MD, FACP, Protocol chair		Ph: 773-702-4400; 888-824-0200 Email: wstadler@medicine.bsd.uchicago.edu

Registry Information
Official Title		Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin with Amifostine Cytoprotection in Patients with Locally Advanced Bladder Cancer
Trial Start Date		2000-06-29
Registered in ClinicalTrials.gov		NCT00006105
Date Submitted to PDQ		2000-06-29
Information Last Verified		2004-11-01
NCI Grant/Contract Number		P30-CA14599

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