Eflornithine in Treating Patients With Bladder Cancer

December 17, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mark Mayle, Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1999

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

February 19, 2004

First Posted (Estimate)

February 20, 2004

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

May 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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