Bladder Cancer, Drug/Agent Toxicity by Tissue/Organ
Conditions
Keywords
stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, drug/agent toxicity by tissue/organ
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.
Interventions
DRUGamifostine trihydrate
DRUGcisplatin
DRUGgemcitabine hydrochloride
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effects of cisplatin/gemcitabine in combination with amifostine | 4 months |
Countries
United States
Outcome results
None listed