Eflornithine in Treating Patients With Bladder Cancer

NCT00003814 | Completed Phase 3

• 6 other identifiers: CDR0000066966ILEX-DFMO341UCLA-9812049UF-453-1998WCCC-CO-98803NCI-G99-1509
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 61

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.

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancer; stage I bladder cancer; recurrent bladder cancer; transitional cell carcinoma of the bladder

Interventions

eflornithine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (61)

Urology Associates

Birmingham, Alabama, 35205, United States

Location

Intouch Research

Huntsville, Alabama, 35801, United States

Location

Advanced Urology Medical Center

Anaheim, California, 92801, United States

Location

Citrus Valley Urological Medical Group

Glendora, California, 91741-4164, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

San Diego Urology Center

La Mesa, California, 91942, United States

Location

South Coast Urological Medical Group

Laguna Hills, California, 92653, United States

Location

Foothill Urology Associates

Pasadena, California, 90024, United States

Location

San Bernadino Urological Associates

San Bernadino, California, 92404, United States

Location

DRC and Urological Physicians of San Diego

San Diego, California, 92103, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Urology Specialists, P.C.

Waterbury, Connecticut, 06708, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

Tampa Bay Meical Research

Clearwater, Florida, 33761, United States

Location

University of Florida - Gainesville

Gainesville, Florida, 32610-0277, United States

Location

Urology Health Center

New Port Richey, Florida, 34652, United States

Location

Barzell, Whitmore, Treiman and Dunne - The Urology Treatment Center

Sarasota, Florida, 34239, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Piedmont Urology PC

Atlanta, Georgia, 30309, United States

Location

Georgia Urology

Atlanta, Georgia, 30342, United States

Location

Urology Associates, Inc.

Marietta, Georgia, 30060, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7353, United States

Location

Wichita Clinic, P.A.

Wichita, Kansas, 67208, United States

Location

206 Research Associates

Greenbelt, Maryland, 20770, United States

Location

Mid Atlantic Clinical Research

Rockville, Maryland, 20850, United States

Location

Lahey Clinic - Burlington

Burlington, Massachusetts, 01805, United States

Location

Fallon Clinic, Inc.

Worcester, Massachusetts, 01605, United States

Location

Urology Surgical Associates

Springfield, Missouri, 65804, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Office of Sheldon Freedman

Las Vegas, Nevada, 89109, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

University Hospital of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

St. Joseph West Mesa Center

Albuquerque, New Mexico, 87114, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

Veterans Affairs Medical Center - Albany

Albany, New York, 12208, United States

Location

Medical & Clinical Research Associates, LLC

Bay Shore, New York, 11706, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Oregon Cancer Center

Portland, Oregon, 97201-3098, United States

Location

Earle A. Chiles Research Institute at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Allegheny University of the Health Sciences

Philadelphia, Pennsylvania, 19119, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of North Texas HSC

Fort Worth, Texas, 76107, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Virginia Urology Center

Richmond, Virginia, 23230, United States

Location

Seattle Urological Associates

Seattle, Washington, 98104-1360, United States

Location

Urology Northwest PS

Seattle, Washington, 98133, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Eflornithine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ornithine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino

Study Officials

• Mark Mayle

  Genzyme, a Sanofi Company

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: February 20, 2004
• Study Start: February 1, 1999
• Study Completion: May 1, 2007
• Last Updated: December 18, 2013

Record last verified: 2007-05

Locations

US (61)