Bladder Cancer Clinical Trial
Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
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.
Full 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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Chicago Illinois, 60637, United States
How clear is this clinincal trial information?
![Survivornet Logo](https://assets.survivornet.com/wp-content/uploads/2024/07/10151222/survivornet-logo-blue.png)
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.