Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
| 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
- 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.
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:
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 Lead Organizations
University of Chicago Cancer Research Center
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| Walter Stadler, MD, FACP, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin with Amifostine Cytoprotection in Patients with Locally Advanced Bladder Cancer | |
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| Trial Start Date | 2000-06-29 | |
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| Registered in ClinicalTrials.gov | NCT00006105 | |
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| Date Submitted to PDQ | 2000-06-29 | |
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| Information Last Verified | 2004-11-01 | |
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| NCI Grant/Contract Number | P30-CA14599 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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