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Eflornithine in Treating Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003814
First received: November 1, 1999
Last updated: December 17, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Drug: eflornithine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 450
Study Start Date: February 1999
Study Completion Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003814

  Hide Study Locations
Locations
United States, Alabama
Urology Associates
Birmingham, Alabama, United States, 35205
Intouch Research
Huntsville, Alabama, United States, 35801
United States, California
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
United States, Connecticut
Urology Specialists, P.C.
Waterbury, Connecticut, United States, 06708
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Florida
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
United States, Georgia
Georgia Urology
Atlanta, Georgia, United States, 30342
Piedmont Urology PC
Atlanta, Georgia, United States, 30309
Urology Associates, Inc.
Marietta, Georgia, United States, 30060
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7353
Wichita Clinic, P.A.
Wichita, Kansas, United States, 67208
United States, Maryland
206 Research Associates
Greenbelt, Maryland, United States, 20770
Mid Atlantic Clinical Research
Rockville, Maryland, United States, 20850
United States, Massachusetts
Lahey Clinic - Burlington
Burlington, Massachusetts, United States, 01805
Fallon Clinic, Inc.
Worcester, Massachusetts, United States, 01605
United States, Missouri
Washington University Barnard Cancer Center
Saint Louis, Missouri, United States, 63110
Urology Surgical Associates
Springfield, Missouri, United States, 65804
United States, Nevada
Office of Sheldon Freedman
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
St. Joseph West Mesa Center
Albuquerque, New Mexico, United States, 87114
University Hospital of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
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
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Oregon Cancer Center
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
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
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Urology Clinics of North Texas
Dallas, Texas, United States, 75231
University of North Texas HSC
Fort Worth, Texas, United States, 76107
Urology San Antonio Research
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23507
Virginia Urology Center
Richmond, Virginia, United States, 23230
United States, Washington
Seattle Urological Associates
Seattle, Washington, United States, 98104-1360
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Urology Northwest PS
Seattle, Washington, United States, 98133
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Investigators
Study Chair: Mark Mayle Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003814     History of Changes
Other Study ID Numbers: CDR0000066966, ILEX-DFMO341, UCLA-9812049, UF-453-1998, WCCC-CO-98803, NCI-G99-1509
Study First Received: November 1, 1999
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Eflornithine
Anti-Infective Agents
Antineoplastic Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on November 24, 2014