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Completed Phase 3 Interventional

Eflornithine in Treating Patients With Bladder Cancer

ClinicalTrials.gov ID: NCT00003814

Public ClinicalTrials.gov record NCT00003814. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 8:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00003814
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
450 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 1999 (Type not available)
Primary completion
Not listed
Completion
May 2007 (Actual)
Last update posted
Dec 18, 2013

1999 – 2007

United States locations

U.S. sites
61
U.S. states
26
U.S. cities
52
Facility City State ZIP Site status
Urology Associates Birmingham Alabama 35205 —
Intouch Research Huntsville Alabama 35801 —
Advanced Urology Medical Center Anaheim California 92801 —
Citrus Valley Urological Medical Group Glendora California 91741-4164 —
University of California San Diego Cancer Center La Jolla California 92093-0658 —
San Diego Urology Center La Mesa California 91942 —
South Coast Urological Medical Group Laguna Hills California 92653 —
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 —
UCSF Cancer Center and Cancer Research Institute San Francisco California 94143-0128 —
Urology Specialists, P.C. Waterbury Connecticut 06708 —
George Washington University Hospital Washington D.C. District of Columbia 20037 —
Tampa Bay Meical Research Clearwater Florida 33761 —
University of Florida - Gainesville Gainesville Florida 32610-0277 —
Urology Health Center New Port Richey Florida 34652 —
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center Sarasota Florida 34239 —
H. Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612-9497 —
Piedmont Urology PC Atlanta Georgia 30309 —
Georgia Urology Atlanta Georgia 30342 —
Urology Associates, Inc. Marietta Georgia 30060 —
University of Chicago Cancer Research Center Chicago Illinois 60637-1470 —
Indiana University Cancer Center Indianapolis Indiana 46202-5289 —
University of Kansas Medical Center Kansas City Kansas 66160-7353 —
Wichita Clinic, P.A. Wichita Kansas 67208 —
206 Research Associates Greenbelt Maryland 20770 —
Mid Atlantic Clinical Research Rockville Maryland 20850 —
Lahey Clinic - Burlington Burlington Massachusetts 01805 —
Fallon Clinic, Inc. Worcester Massachusetts 01605 —
Urology Surgical Associates Springfield Missouri 65804 —
Washington University Barnard Cancer Center St Louis Missouri 63110 —
Office of Sheldon Freedman Las Vegas Nevada 89109 —
Robert Wood Johnson Medical School New Brunswick New Jersey 08903 —
University Hospital of New Mexico Albuquerque New Mexico 87106 —
St. Joseph West Mesa Center Albuquerque New Mexico 87114 —
Cancer Center of Albany Medical Center Albany New York 12208 —
Veterans Affairs Medical Center - Albany Albany New York 12208 —
Medical & Clinical Research Associates, LLC Bay Shore New York 11706 —
Mount Sinai Medical Center, NY New York New York 10029 —
University of Rochester Cancer Center Rochester New York 14642 —
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195 —
Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio 43210-1240 —
University of Oklahoma College of Medicine Oklahoma City Oklahoma 73190 —
Oregon Cancer Center Portland Oregon 97201-3098 —
Earle A. Chiles Research Institute at Providence Portland Medical Center Portland Oregon 97213-2967 —
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania 19107-5541 —
Allegheny University of the Health Sciences Philadelphia Pennsylvania 19119 —
Albert Einstein Cancer Center Philadelphia Pennsylvania 19141 —
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232-6838 —
Urology Clinics of North Texas Dallas Texas 75231 —
Simmons Cancer Center - Dallas Dallas Texas 75235-9154 —
University of North Texas HSC Fort Worth Texas 76107 —
Urology San Antonio Research San Antonio Texas 78229 —
Huntsman Cancer Institute Salt Lake City Utah 84112 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —
Virginia Urology Center Richmond Virginia 23230 —
Seattle Urological Associates Seattle Washington 98104-1360 —
Urology Northwest PS Seattle Washington 98133 —
University of Washington Medical Center Seattle Washington 98195-6043 —
Madigan Army Medical Center Tacoma Washington 98431-5000 —
University of Wisconsin Comprehensive Cancer Center Madison Wisconsin 53792-6164 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00003814, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 18, 2013 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00003814 live on ClinicalTrials.gov.

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