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.

Condition	Treatment or Intervention	Phase
stage II bladder cancer stage III bladder cancer stage IV bladder cancer Drug Toxicity	Drug: amifostine  Drug: cisplatin  Drug: gemcitabine  Procedure: adjuvant therapy  Procedure: chemoprotection  Procedure: chemotherapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

PATIENT CHARACTERISTICS: Age:

• 18 and over

Performance status:

• Karnofsky 70-100

Life expectancy:

• At least 12 weeks

Hematopoietic:

• WBC at least 3,500/mm^3
• Platelet count at least 100,000/mm^3
• 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

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

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

Study chairs or principal investigators

Walter M. Stadler, MD,  Study Chair,  University of Chicago Cancer Research Center   

Study ID Numbers:  CDR0000068116; UCCRC-9193; UCCRC-CTRC-9806; NCI-G00-1831
Record last reviewed:  December 2004
Last Updated:  December 9, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006105
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08