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
PHASE3
450 participants
INTERVENTIONAL
1999-02-28
2007-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in treating patients who have newly diagnosed or recurrent bladder cancer.
Detailed Description
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OUTLINE: This is a randomized, double blind, multicenter study. Patients are stratified according to disease status (newly diagnosed vs recurrent), clinical stage (Ta vs T1), grade (G1 vs G2), and focus (multifocal vs unifocal). Patients receive either oral eflornithine or placebo once daily. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months during the first 2 years, every 6 months for the third year, and then annually for the fourth year.
PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued to this study within 1.5 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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eflornithine
Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within the past 5 years and no concurrent malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No clinically significant hearing loss (i.e., hearing loss effects everyday life and/or wears a hearing aide) No other significant medical or psychiatric condition
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior growth factors No concurrent growth factors Chemotherapy: No prior systemic chemotherapy for bladder cancer No concurrent intravesical therapy At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior high dose steroids or prednisone No concurrent high dose steroids No concurrent prednisone or its equivalent in excess of 10 mg/day Radiotherapy: No prior radiotherapy for bladder cancer At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior carbamazepine or experimental drugs No concurrent carbamazepine or experimental drugs
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Principal Investigators
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Mark Mayle
Role: STUDY_CHAIR
Genzyme, a Sanofi Company
Locations
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Urology Associates
Birmingham, Alabama, United States
Intouch Research
Huntsville, Alabama, United States
Advanced Urology Medical Center
Anaheim, California, United States
Citrus Valley Urological Medical Group
Glendora, California, United States
University of California San Diego Cancer Center
La Jolla, California, United States
San Diego Urology Center
La Mesa, California, United States
South Coast Urological Medical Group
Laguna Hills, California, United States
Foothill Urology Associates
Pasadena, California, United States
San Bernadino Urological Associates
San Bernadino, California, United States
DRC and Urological Physicians of San Diego
San Diego, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Urology Specialists, P.C.
Waterbury, Connecticut, United States
George Washington University Hospital
Washington D.C., District of Columbia, United States
Tampa Bay Meical Research
Clearwater, Florida, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Urology Health Center
New Port Richey, Florida, United States
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center
Sarasota, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Piedmont Urology PC
Atlanta, Georgia, United States
Georgia Urology
Atlanta, Georgia, United States
Urology Associates, Inc.
Marietta, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Wichita Clinic, P.A.
Wichita, Kansas, United States
206 Research Associates
Greenbelt, Maryland, United States
Mid Atlantic Clinical Research
Rockville, Maryland, United States
Lahey Clinic - Burlington
Burlington, Massachusetts, United States
Fallon Clinic, Inc.
Worcester, Massachusetts, United States
Urology Surgical Associates
Springfield, Missouri, United States
Washington University Barnard Cancer Center
St Louis, Missouri, United States
Office of Sheldon Freedman
Las Vegas, Nevada, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
University Hospital of New Mexico
Albuquerque, New Mexico, United States
St. Joseph West Mesa Center
Albuquerque, New Mexico, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
Veterans Affairs Medical Center - Albany
Albany, New York, United States
Medical & Clinical Research Associates, LLC
Bay Shore, New York, United States
Mount Sinai Medical Center, NY
New York, New York, United States
University of Rochester Cancer Center
Rochester, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Oregon Cancer Center
Portland, Oregon, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny University of the Health Sciences
Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of North Texas HSC
Fort Worth, Texas, United States
Urology San Antonio Research
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Urology Center
Richmond, Virginia, United States
Seattle Urological Associates
Seattle, Washington, United States
Urology Northwest PS
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ILEX-DFMO341
Identifier Type: -
Identifier Source: secondary_id
UCLA-9812049
Identifier Type: -
Identifier Source: secondary_id
UF-453-1998
Identifier Type: -
Identifier Source: secondary_id
WCCC-CO-98803
Identifier Type: -
Identifier Source: secondary_id
NCI-G99-1509
Identifier Type: -
Identifier Source: secondary_id
CDR0000066966
Identifier Type: -
Identifier Source: org_study_id