- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003814
Eflornithine in Treating Patients With Bladder Cancer
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
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
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Urology Associates
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Huntsville, Alabama, United States, 35801
- Intouch Research
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California
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Anaheim, California, United States, 92801
- Advanced Urology Medical Center
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Glendora, California, United States, 91741-4164
- Citrus Valley Urological Medical Group
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La Jolla, California, United States, 92093-0658
- University of California San Diego Cancer Center
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La Mesa, California, United States, 91942
- San Diego Urology Center
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Laguna Hills, California, United States, 92653
- South Coast Urological Medical Group
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Pasadena, California, United States, 90024
- Foothill Urology Associates
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San Bernadino, California, United States, 92404
- San Bernadino Urological Associates
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San Diego, California, United States, 92103
- DRC and Urological Physicians of San Diego
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Connecticut
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Waterbury, Connecticut, United States, 06708
- Urology Specialists, P.C.
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University Hospital
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Florida
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Clearwater, Florida, United States, 33761
- Tampa Bay Meical Research
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Gainesville, Florida, United States, 32610-0277
- University of Florida - Gainesville
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New Port Richey, Florida, United States, 34652
- Urology Health Center
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Sarasota, Florida, United States, 34239
- Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center
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Tampa, Florida, United States, 33612-9497
- H. Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, United States, 30342
- Georgia Urology
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Atlanta, Georgia, United States, 30309
- Piedmont Urology PC
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Marietta, Georgia, United States, 30060
- Urology Associates, Inc.
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Illinois
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Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Kansas
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Kansas City, Kansas, United States, 66160-7353
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67208
- Wichita Clinic, P.A.
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Maryland
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Greenbelt, Maryland, United States, 20770
- 206 Research Associates
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Rockville, Maryland, United States, 20850
- Mid Atlantic Clinical Research
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Massachusetts
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic - Burlington
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Worcester, Massachusetts, United States, 01605
- Fallon Clinic, Inc.
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University Barnard Cancer Center
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Springfield, Missouri, United States, 65804
- Urology Surgical Associates
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Nevada
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Las Vegas, Nevada, United States, 89109
- Office of Sheldon Freedman
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Robert Wood Johnson Medical School
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- University Hospital of New Mexico
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Albuquerque, New Mexico, United States, 87114
- St. Joseph West Mesa Center
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New York
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Albany, New York, United States, 12208
- Cancer Center of Albany Medical Center
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Albany, New York, United States, 12208
- Veterans Affairs Medical Center - Albany
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Bay Shore, New York, United States, 11706
- Medical & Clinical Research Associates, LLC
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New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
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Rochester, New York, United States, 14642
- University of Rochester Cancer Center
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Taussig Cancer Center
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Columbus, Ohio, United States, 43210-1240
- Arthur G. James Cancer Hospital - Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma College of Medicine
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Oregon
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Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center
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Portland, Oregon, United States, 97213-2967
- Earle A. Chiles Research Institute at Providence Portland Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Cancer Center
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Philadelphia, Pennsylvania, United States, 19107-5541
- Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
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Philadelphia, Pennsylvania, United States, 19119
- Allegheny University of the Health Sciences
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Dallas, Texas, United States, 75231
- Urology Clinics of North Texas
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Fort Worth, Texas, United States, 76107
- University of North Texas HSC
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San Antonio, Texas, United States, 78229
- Urology San Antonio Research
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Utah
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Salt Lake City, Utah, United States, 84112
- Huntsman Cancer Institute
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Virginia
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Norfolk, Virginia, United States, 23507
- Sentara Norfolk General Hospital
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Richmond, Virginia, United States, 23230
- Virginia Urology Center
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Washington
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Seattle, Washington, United States, 98195-6043
- University of Washington Medical Center
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Seattle, Washington, United States, 98104-1360
- Seattle Urological Associates
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Seattle, Washington, United States, 98133
- Urology Northwest PS
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Tacoma, Washington, United States, 98431-5000
- Madigan Army Medical Center
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Wisconsin
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Mark Mayle, Genzyme, a Sanofi Company
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Trypanocidal Agents
- Ornithine Decarboxylase Inhibitors
- Eflornithine
Other Study ID Numbers
- CDR0000066966
- ILEX-DFMO341
- UCLA-9812049
- UF-453-1998
- WCCC-CO-98803
- NCI-G99-1509
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.
Clinical Trials on Bladder Cancer
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University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | No Evidence of Disease | Stage II Bladder Cancer | Stage IVA Bladder Cancer | Stage IVB Bladder CancerUnited States
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H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Cancer | Urinary Complications | Stage 0 Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder Cancer
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Fox Chase Cancer CenterTerminatedStage III Bladder Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Squamous Cell Carcinoma of the Bladder | Urethral Cancer Associated With Invasive Bladder Cancer | Stage II Bladder CancerUnited States
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National Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Stage II Bladder CancerUnited States
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Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
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Taris Biomedical LLCBristol-Myers SquibbTerminatedBladder Cancer TNM Staging Primary Tumor (T) T2 | Bladder Cancer TNM Staging Primary Tumor (T) T2A | Bladder Cancer TNM Staging Primary Tumor (T) T2B | Bladder Cancer TNM Staging Primary Tumor (T) T3 | Bladder Cancer TNM Staging Primary Tumor (T) T3A | Bladder Cancer TNM Staging Primary Tumor... and other conditionsUnited States
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National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
Clinical Trials on eflornithine
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Orbus Therapeutics, Inc.RecruitingGlioblastoma | Glioblastoma Multiforme | GBM | Glioblastoma, IDH-wildtype | Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeUnited States
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Walter Reed National Military Medical CenterTerminatedPseudofolliculitis BarbaeUnited States
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SWOG Cancer Research NetworkNational Cancer Institute (NCI); Cancer Prevention Pharmaceuticals, Inc.Active, not recruiting
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University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedNon-melanomatous Skin Cancer
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Hordinsky, Maria K., MDCompletedPseudofolliculitis BarbaeUnited States
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Giselle ShollerBeat NB Cancer Foundation; Team Parker for LifeRecruiting
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Thomas E. AhleringNational Cancer Institute (NCI)CompletedProstate CancerUnited States
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Bispebjerg HospitalCompleted
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); Cancer Prevention Pharmaceuticals, Inc.Active, not recruitingGastric Cancer | Gastric Intestinal MetaplasiaHonduras, Puerto Rico