Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
NCT ID: NCT00006105
Last Updated: 2013-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
37 participants
INTERVENTIONAL
2000-06-30
2006-09-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
amifostine trihydrate
cisplatin
gemcitabine hydrochloride
adjuvant therapy
Interventions
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amifostine trihydrate
cisplatin
gemcitabine hydrochloride
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Walter M. Stadler, MD, FACP
Role: STUDY_CHAIR
University of Chicago
Locations
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University of Chicago Cancer Research Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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UCCRC-9193
Identifier Type: -
Identifier Source: secondary_id
UCCRC-CTRC-9806
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1831
Identifier Type: -
Identifier Source: secondary_id
9193
Identifier Type: -
Identifier Source: org_study_id