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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006105 |
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.
Condition | Intervention | Phase |
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Bladder Cancer Cancer-Related Problem/Condition |
Drug: amifostine trihydrate Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer |
Study Start Date: | June 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Completely resected locally advanced bladder cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 |
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000068116, UCCRC-9193, UCCRC-CTRC-9806, NCI-G00-1831 |
Study First Received: | August 3, 2000 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00006105 |
Health Authority: | United States: Federal Government |
stage II bladder cancer stage III bladder cancer stage IV bladder cancer drug/agent toxicity by tissue/organ |
Cystocele Amifostine Cisplatin Urologic Diseases Urinary Bladder Diseases Urinary Bladder Neoplasms |
Urogenital Neoplasms Gemcitabine Urologic Neoplasms Urinary tract neoplasm Bladder neoplasm |
Antimetabolites Anti-Infective Agents Radiation-Protective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Protective Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |