Clinical trial NCT00003814: Eflornithine in Treating Patients With Bladder Cancer
Official title: Phase III Randomized, Double-Blind Study of DFMO vs. Placebo in Low Grade Superficial Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bladder Cancer
Keywords: stage 0 bladder cancer
stage I bladder cancer
recurrent bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-02-20
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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 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

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