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Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer (NCT00003814)

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.
  • Drug: eflornithine
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    61 locations

    United States (61)
    • Urology Associates
      Birmingham, Alabama, United States, 35205
    • Intouch Research
      Huntsville, Alabama, United States, 35801
    • Advanced Urology Medical Center
      Anaheim, California, United States, 92801
    • Citrus Valley Urological Medical Group
      Glendora, California, United States, 91741-4164
    • University of California San Diego Cancer Center
      La Jolla, California, United States, 92093-0658
    • San Diego Urology Center
      La Mesa, California, United States, 91942
    • South Coast Urological Medical Group
      Laguna Hills, California, United States, 92653
    • Foothill Urology Associates
      Pasadena, California, United States, 90024
    • San Bernadino Urological Associates
      San Bernadino, California, United States, 92404
    • DRC and Urological Physicians of San Diego
      San Diego, California, United States, 92103
    • UCSF Cancer Center and Cancer Research Institute
      San Francisco, California, United States, 94143-0128
    • Urology Specialists, P.C.
      Waterbury, Connecticut, United States, 06708
    • George Washington University Hospital
      Washington, District of Columbia, United States, 20037
    • Tampa Bay Meical Research
      Clearwater, Florida, United States, 33761
    • University of Florida - Gainesville
      Gainesville, Florida, United States, 32610-0277
    • Urology Health Center
      New Port Richey, Florida, United States, 34652
    • Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center
      Sarasota, Florida, United States, 34239
    • H. Lee Moffitt Cancer Center and Research Institute
      Tampa, Florida, United States, 33612-9497
    • Piedmont Urology PC
      Atlanta, Georgia, United States, 30309
    • Georgia Urology
      Atlanta, Georgia, United States, 30342
    • Urology Associates, Inc.
      Marietta, Georgia, United States, 30060
    • University of Chicago Cancer Research Center
      Chicago, Illinois, United States, 60637-1470
    • Indiana University Cancer Center
      Indianapolis, Indiana, United States, 46202-5289
    • University of Kansas Medical Center
      Kansas City, Kansas, United States, 66160-7353
    • Wichita Clinic, P.A.
      Wichita, Kansas, United States, 67208
    • 206 Research Associates
      Greenbelt, Maryland, United States, 20770
    • Mid Atlantic Clinical Research
      Rockville, Maryland, United States, 20850
    • Lahey Clinic - Burlington
      Burlington, Massachusetts, United States, 01805
    • Fallon Clinic, Inc.
      Worcester, Massachusetts, United States, 01605
    • Washington University Barnard Cancer Center
      Saint Louis, Missouri, United States, 63110
    • Urology Surgical Associates
      Springfield, Missouri, United States, 65804
    • Office of Sheldon Freedman
      Las Vegas, Nevada, United States, 89109
    • Robert Wood Johnson Medical School
      New Brunswick, New Jersey, United States, 08903
    • University Hospital of New Mexico
      Albuquerque, New Mexico, United States, 87106
    • St. Joseph West Mesa Center
      Albuquerque, New Mexico, United States, 87114
    • Cancer Center of Albany Medical Center
      Albany, New York, United States, 12208
    • Veterans Affairs Medical Center - Albany
      Albany, New York, United States, 12208
    • Medical & Clinical Research Associates, LLC
      Bay Shore, New York, United States, 11706
    • Mount Sinai Medical Center, NY
      New York, New York, United States, 10029
    • University of Rochester Cancer Center
      Rochester, New York, United States, 14642
    • Cleveland Clinic Taussig Cancer Center
      Cleveland, Ohio, United States, 44195
    • Arthur G. James Cancer Hospital - Ohio State University
      Columbus, Ohio, United States, 43210-1240
    • University of Oklahoma College of Medicine
      Oklahoma City, Oklahoma, United States, 73190
    • Oregon Cancer Center
      Portland, Oregon, United States, 97201-3098
    • Earle A. Chiles Research Institute at Providence Portland Medical Center
      Portland, Oregon, United States, 97213-2967
    • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
      Philadelphia, Pennsylvania, United States, 19107-5541
    • Allegheny University of the Health Sciences
      Philadelphia, Pennsylvania, United States, 19119
    • Albert Einstein Cancer Center
      Philadelphia, Pennsylvania, United States, 19141
    • Vanderbilt-Ingram Cancer Center
      Nashville, Tennessee, United States, 37232-6838
    • Urology Clinics of North Texas
      Dallas, Texas, United States, 75231
    • Simmons Cancer Center - Dallas
      Dallas, Texas, United States, 75235-9154
    • University of North Texas HSC
      Fort Worth, Texas, United States, 76107
    • Urology San Antonio Research
      San Antonio, Texas, United States, 78229
    • Huntsman Cancer Institute
      Salt Lake City, Utah, United States, 84112
    • Sentara Norfolk General Hospital
      Norfolk, Virginia, United States, 23507
    • Virginia Urology Center
      Richmond, Virginia, United States, 23230
    • Seattle Urological Associates
      Seattle, Washington, United States, 98104-1360
    • Urology Northwest PS
      Seattle, Washington, United States, 98133
    • University of Washington Medical Center
      Seattle, Washington, United States, 98195-6043
    • Madigan Army Medical Center
      Tacoma, Washington, United States, 98431-5000
    • University of Wisconsin Comprehensive Cancer Center
      Madison, Wisconsin, United States, 53792-6164
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 January, 1999
    Updated:
    16 December, 2013
    Participants:
    450
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