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


Phase 3
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mark Mayle

Investigator Role:

Study Chair

Investigator Affiliation:

Genzyme

Authority:

United States: Federal Government

Study ID:

CDR0000066966

NCT ID:

NCT00003814

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage 0 bladder cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • transitional cell carcinoma of the bladder
  • Urinary Bladder Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Cancer Center of Albany Medical CenterAlbany, New York  12208
University of Rochester Cancer CenterRochester, New York  14642
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Washington Medical CenterSeattle, Washington  98195-6043
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Mount Sinai Medical Center, NYNew York, New York  10029
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Veterans Affairs Medical Center - AlbanyAlbany, New York  12208
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Madigan Army Medical CenterTacoma, Washington  98431-5048
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Oregon Cancer CenterPortland, Oregon  97201-3098
George Washington University HospitalWashington, District of Columbia  20037
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Earle A. Chiles Research Institute at Providence Portland Medical CenterPortland, Oregon  97213-2967
Advanced Urology Medical CenterAnaheim, California  92801
South Coast Urological Medical GroupLaguana Hills, California  92653
Urology Specialists, P.C.Waterbury, Connecticut  06708
Barzell, Whitmore, Treiman and Dunne - The Urology Treatment CenterSarasota, Florida  34239
206 Research AssociatesGreenbelt, Maryland  20770
Mid Atlantic Clinical ResearchRockville, Maryland  20850
Medical & Clinical Research Associates, LLCBay Shore, New York  11706
Urology San Antonio ResearchSan Antonio, Texas  78229
University of Florida - GainesvilleGainesville, Florida  32610-0277
Urology AssociatesBirmingham, Alabama  35205
San Diego Urology CenterLa Mesa, California  91942
Urology Health CenterNew Port Richey, Florida  34652
Georgia UrologyAtlanta, Georgia  30342
Virginia Urology CenterRichmond, Virginia  23230
Intouch ResearchHuntsville, Alabama  35801
Citrus Valley Urological Medical GroupGlendora, California  91741-4164
Foothill Urology AssociatesPasadena, California  90024
San Bernadino Urological AssociatesSan Bernadino, California  92404
DRC and Urological Physicians of San DiegoSan Diego, California  92103
Tampa Bay Meical ResearchClearwater, Florida  33761
Piedmont Urology PCAtlanta, Georgia  30309
Urology Associates, Inc.Marietta, Georgia  30060
Wichita Clinic, P.A.Wichita, Kansas  67208
Fallon Clinic, Inc.Worcester, Massachusetts  01605
Urology Surgical AssociatesSpringfield, Missouri  65804
Office of Sheldon FreedmanLas Vegas, Nevada  89109
St. Joseph West Mesa CenterAlbuquerque, New Mexico  87114
University Hospital of New MexicoAlbuquerque, New Mexico  87106
Allegheny University of the Health SciencesPhiladelphia, Pennsylvania  19119
Urology Clinics of North TexasDallas, Texas  75231
University of North Texas HSCFort Worth, Texas  76107
Sentara Norfolk General HospitalNorfolk, Virginia  23507
Seattle Urological AssociatesSeattle, Washington  98104-1360
Urology Northwest PSSeattle, Washington  98133