Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Mark Mayle
Study Chair
Genzyme
United States: Federal Government
CDR0000066966
NCT00003814
February 1999
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Veterans Affairs Medical Center - Albany | Albany, New York 12208 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Lahey Clinic - Burlington | Burlington, Massachusetts 01805 |
Oregon Cancer Center | Portland, Oregon 97201-3098 |
George Washington University Hospital | Washington, District of Columbia 20037 |
Washington University Barnard Cancer Center | Saint Louis, Missouri 63110 |
Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
Advanced Urology Medical Center | Anaheim, California 92801 |
South Coast Urological Medical Group | Laguana Hills, California 92653 |
Urology Specialists, P.C. | Waterbury, Connecticut 06708 |
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center | Sarasota, Florida 34239 |
206 Research Associates | Greenbelt, Maryland 20770 |
Mid Atlantic Clinical Research | Rockville, Maryland 20850 |
Medical & Clinical Research Associates, LLC | Bay Shore, New York 11706 |
Urology San Antonio Research | San Antonio, Texas 78229 |
University of Florida - Gainesville | Gainesville, Florida 32610-0277 |
Urology Associates | Birmingham, Alabama 35205 |
San Diego Urology Center | La Mesa, California 91942 |
Urology Health Center | New Port Richey, Florida 34652 |
Georgia Urology | Atlanta, Georgia 30342 |
Virginia Urology Center | Richmond, Virginia 23230 |
Intouch Research | Huntsville, Alabama 35801 |
Citrus Valley Urological Medical Group | Glendora, California 91741-4164 |
Foothill Urology Associates | Pasadena, California 90024 |
San Bernadino Urological Associates | San Bernadino, California 92404 |
DRC and Urological Physicians of San Diego | San Diego, California 92103 |
Tampa Bay Meical Research | Clearwater, Florida 33761 |
Piedmont Urology PC | Atlanta, Georgia 30309 |
Urology Associates, Inc. | Marietta, Georgia 30060 |
Wichita Clinic, P.A. | Wichita, Kansas 67208 |
Fallon Clinic, Inc. | Worcester, Massachusetts 01605 |
Urology Surgical Associates | Springfield, Missouri 65804 |
Office of Sheldon Freedman | Las Vegas, Nevada 89109 |
St. Joseph West Mesa Center | Albuquerque, New Mexico 87114 |
University Hospital of New Mexico | Albuquerque, New Mexico 87106 |
Allegheny University of the Health Sciences | Philadelphia, Pennsylvania 19119 |
Urology Clinics of North Texas | Dallas, Texas 75231 |
University of North Texas HSC | Fort Worth, Texas 76107 |
Sentara Norfolk General Hospital | Norfolk, Virginia 23507 |
Seattle Urological Associates | Seattle, Washington 98104-1360 |
Urology Northwest PS | Seattle, Washington 98133 |