Eflornithine in Treating Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003814
• Other study ID #: CDR0000066966
• Secondary ID: ILEX-DFMO341UCLA
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 17, 2013
• Start date: February 1999
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• eflornithine

Locations

Country	Name	City	State
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Veterans Affairs Medical Center - Albany	Albany	New York
United States	St. Joseph West Mesa Center	Albuquerque	New Mexico
United States	University Hospital of New Mexico	Albuquerque	New Mexico
United States	Advanced Urology Medical Center	Anaheim	California
United States	Georgia Urology	Atlanta	Georgia
United States	Piedmont Urology PC	Atlanta	Georgia
United States	Medical & Clinical Research Associates, LLC	Bay Shore	New York
United States	Urology Associates	Birmingham	Alabama
United States	Lahey Clinic - Burlington	Burlington	Massachusetts
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Tampa Bay Meical Research	Clearwater	Florida
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Urology Clinics of North Texas	Dallas	Texas
United States	University of North Texas HSC	Fort Worth	Texas
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Citrus Valley Urological Medical Group	Glendora	California
United States	206 Research Associates	Greenbelt	Maryland
United States	Intouch Research	Huntsville	Alabama
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California San Diego Cancer Center	La Jolla	California
United States	San Diego Urology Center	La Mesa	California
United States	South Coast Urological Medical Group	Laguna Hills	California
United States	Office of Sheldon Freedman	Las Vegas	Nevada
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Urology Associates, Inc.	Marietta	Georgia
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Urology Health Center	New Port Richey	Florida
United States	Mount Sinai Medical Center, NY	New York	New York
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Foothill Urology Associates	Pasadena	California
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Allegheny University of the Health Sciences	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Earle A. Chiles Research Institute at Providence Portland Medical Center	Portland	Oregon
United States	Oregon Cancer Center	Portland	Oregon
United States	Virginia Urology Center	Richmond	Virginia
United States	University of Rochester Cancer Center	Rochester	New York
United States	Mid Atlantic Clinical Research	Rockville	Maryland
United States	Washington University Barnard Cancer Center	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Urology San Antonio Research	San Antonio	Texas
United States	San Bernadino Urological Associates	San Bernadino	California
United States	DRC and Urological Physicians of San Diego	San Diego	California
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center	Sarasota	Florida
United States	Seattle Urological Associates	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Urology Northwest PS	Seattle	Washington
United States	Urology Surgical Associates	Springfield	Missouri
United States	Madigan Army Medical Center	Tacoma	Washington
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	George Washington University Hospital	Washington	District of Columbia
United States	Urology Specialists, P.C.	Waterbury	Connecticut
United States	Wichita Clinic, P.A.	Wichita	Kansas
United States	Fallon Clinic, Inc.	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,