Eflornithine in Treating Patients With Bladder Cancer
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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 |
| Estimated Enrollment: | 450 |
| Study Start Date: | February 1999 |
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 |
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
Hide Study 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 | |
| Albert Einstein Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Allegheny University of the Health Sciences | |
| Philadelphia, Pennsylvania, United States, 19119 | |
| Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| 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 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195-6043 | |
| Seattle Urological Associates | |
| Seattle, Washington, United States, 98104-1360 | |
| 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 | |
| Study Chair: | Mark Mayle | Genzyme |
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: | July 23, 2008 |
| 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 Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Eflornithine Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013