Eflornithine in Treating Patients With Bladder Cancer
- Conditions
- Bladder Cancer
- Registration Number
- NCT00003814
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if eflornithine is more effective than no further therapy in treating bladder cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of eflornithine in treating patients who have newly diagnosed or recurrent bladder cancer.
- Detailed Description
OBJECTIVES: I. Determine whether treatment with eflornithine is effective in preventing recurrence of tumor after transurethral resection in patients with low grade, superficial transitional cell carcinoma of the bladder. II. Determine the incidence and severity of toxicities associated with the long-term use of this drug in this patient population.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Simmons Cancer Center - Dallas
🇺🇸Dallas, Texas, United States
Piedmont Urology PC
🇺🇸Atlanta, Georgia, United States
Georgia Urology
🇺🇸Atlanta, Georgia, United States
Wichita Clinic, P.A.
🇺🇸Wichita, Kansas, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Urology Specialists, P.C.
🇺🇸Waterbury, Connecticut, United States
Urology Associates
🇺🇸Birmingham, Alabama, 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
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
Office of Sheldon Freedman
🇺🇸Las Vegas, Nevada, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Urology Northwest PS
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Intouch Research
🇺🇸Huntsville, Alabama, United States
South Coast Urological Medical Group
🇺🇸Laguna Hills, California, United States
Advanced Urology Medical Center
🇺🇸Anaheim, California, United States
Allegheny University of the Health Sciences
🇺🇸Philadelphia, Pennsylvania, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Virginia Urology Center
🇺🇸Richmond, Virginia, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Urological Associates
🇺🇸Seattle, Washington, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Oregon Cancer Center
🇺🇸Portland, Oregon, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
University of Rochester Cancer Center
🇺🇸Rochester, New York, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
206 Research Associates
🇺🇸Greenbelt, Maryland, United States
University of Oklahoma College of Medicine
🇺🇸Oklahoma City, Oklahoma, United States
Citrus Valley Urological Medical Group
🇺🇸Glendora, California, United States
San Diego Urology Center
🇺🇸La Mesa, California, United States
San Bernadino Urological Associates
🇺🇸San Bernadino, California, United States
Tampa Bay Meical Research
🇺🇸Clearwater, Florida, United States
Urology Health Center
🇺🇸New Port Richey, Florida, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Urology Associates, Inc.
🇺🇸Marietta, Georgia, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Lahey Clinic - Burlington
🇺🇸Burlington, Massachusetts, United States
Mid Atlantic Clinical Research
🇺🇸Rockville, Maryland, United States
Fallon Clinic, Inc.
🇺🇸Worcester, Massachusetts, United States
Urology Surgical Associates
🇺🇸Springfield, Missouri, United States
Washington University Barnard Cancer Center
🇺🇸Saint Louis, Missouri, 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
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Foothill Urology Associates
🇺🇸Pasadena, California, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
University of North Texas HSC
🇺🇸Fort Worth, Texas, United States
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center
🇺🇸Sarasota, Florida, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States