Eflornithine in Treating Patients With Bladder Cancer

Last updated: December 17, 2013
Sponsor: National Cancer Institute (NCI)
Overall Status: Completed

Phase

3

Condition

Bladder Cancer

Urothelial Cancer

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT00003814
CDR0000066966
NCI-G99-1509
ILEX-DFMO341
WCCC-CO-98803
UF-453-1998
UCLA-9812049
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Histologically confirmed low grade (grade 1 or 2), superficial (stage Ta or T1) transitional cell carcinoma (TCC) of the bladder Newly diagnosed or recurrent All visible tumor must have been resected within the past 12 weeks Standard clinical management determined to be expectant observation without further surgery, intravesical therapy, or systemic therapy No prior upper tract TCC No history of grade 3 TCC, carcinoma in situ including severe dysplasia, non-TCC histology, or TCC greater than or equal to T2 No involvement of upper urinary tract prior to or at the time of initial tumor resection Abdominal CT scan, IVP, or retrograde pyelogram within the past 3 months to rule out upper urinary tract tumor

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

Study Design

Total Participants: 450
Study Start date:
February 01, 1999
Estimated Completion Date:
May 31, 2007

Study 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.

Connect with a study center

  • Urology Associates

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Intouch Research

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Advanced Urology Medical Center

    Anaheim, California 92801
    United States

    Site Not Available

  • Citrus Valley Urological Medical Group

    Glendora, California 91741-4164
    United States

    Site Not Available

  • University of California San Diego Cancer Center

    La Jolla, California 92093-0658
    United States

    Site Not Available

  • San Diego Urology Center

    La Mesa, California 91942
    United States

    Site Not Available

  • South Coast Urological Medical Group

    Laguna Hills, California 92653
    United States

    Site Not Available

  • Foothill Urology Associates

    Pasadena, California 90024
    United States

    Site Not Available

  • San Bernadino Urological Associates

    San Bernadino, California 92404
    United States

    Site Not Available

  • DRC and Urological Physicians of San Diego

    San Diego, California 92103
    United States

    Site Not Available

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California 94143-0128
    United States

    Site Not Available

  • Urology Specialists, P.C.

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Tampa Bay Meical Research

    Clearwater, Florida 33761
    United States

    Site Not Available

  • University of Florida - Gainesville

    Gainesville, Florida 32610-0277
    United States

    Site Not Available

  • Urology Health Center

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center

    Sarasota, Florida 34239
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612-9497
    United States

    Site Not Available

  • Georgia Urology

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Piedmont Urology PC

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • Urology Associates, Inc.

    Marietta, Georgia 30060
    United States

    Site Not Available

  • University of Chicago Cancer Research Center

    Chicago, Illinois 60637-1470
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5289
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160-7353
    United States

    Site Not Available

  • Wichita Clinic, P.A.

    Wichita, Kansas 67208
    United States

    Site Not Available

  • 206 Research Associates

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Mid Atlantic Clinical Research

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Lahey Clinic - Burlington

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Fallon Clinic, Inc.

    Worcester, Massachusetts 01605
    United States

    Site Not Available

  • Washington University Barnard Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Urology Surgical Associates

    Springfield, Missouri 65804
    United States

    Site Not Available

  • Office of Sheldon Freedman

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • St. Joseph West Mesa Center

    Albuquerque, New Mexico 87114
    United States

    Site Not Available

  • University Hospital of New Mexico

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • Cancer Center of Albany Medical Center

    Albany, New York 12208
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Albany

    Albany, New York 12208
    United States

    Site Not Available

  • Medical & Clinical Research Associates, LLC

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Mount Sinai Medical Center, NY

    New York, New York 10029
    United States

    Site Not Available

  • University of Rochester Cancer Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio 43210-1240
    United States

    Site Not Available

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma 73190
    United States

    Site Not Available

  • Earle A. Chiles Research Institute at Providence Portland Medical Center

    Portland, Oregon 97213-2967
    United States

    Site Not Available

  • Oregon Cancer Center

    Portland, Oregon 97201-3098
    United States

    Site Not Available

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • Allegheny University of the Health Sciences

    Philadelphia, Pennsylvania 19119
    United States

    Site Not Available

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania 19107-5541
    United States

    Site Not Available

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232-6838
    United States

    Site Not Available

  • Simmons Cancer Center - Dallas

    Dallas, Texas 75235-9154
    United States

    Site Not Available

  • Urology Clinics of North Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of North Texas HSC

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Urology San Antonio Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Virginia Urology Center

    Richmond, Virginia 23230
    United States

    Site Not Available

  • Seattle Urological Associates

    Seattle, Washington 98104-1360
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195-6043
    United States

    Site Not Available

  • Urology Northwest PS

    Seattle, Washington 98133
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98431-5000
    United States

    Site Not Available

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin 53792-6164
    United States

    Site Not Available

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