Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bladder Cancer; Drug/Agent Toxicity by Tissue/Organ
Intervention: amifostine trihydrate (Drug); cisplatin (Drug); gemcitabine hydrochloride (Drug); adjuvant therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Chicago Official(s) and/or principal investigator(s):
Walter M. Stadler, MD, FACP, Study Chair, Affiliation: University of Chicago
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.
Clinical Details
Official title: Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): 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
Locations and Contacts
University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2000
Last updated: June 17, 2008
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