RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.

Condition	Treatment or Intervention	Phase
transitional cell carcinoma of the bladder stage I bladder cancer stage 0 bladder cancer recurrent bladder cancer	Drug: AD 32	Phase III

Further Study Details: 

OBJECTIVES: I. Assess the efficacy of adjuvant AD 32 following complete transurethral resection versus transurethral resection alone in patients with newly diagnosed or recurrent superficial transitional cell carcinoma of the bladder.

II. Assess the toxicity of AD 32 in these patients.

PROTOCOL OUTLINE: This is an open label, randomized, multicenter study. Patients are randomized to receive surgery with AD 32 or surgery alone.

Arm I: Patients undergo surgery to remove bladder tumors. AD 32 is administered by catheter into the bladder within 2-24 hours after surgery. Patients must hold the AD 32 liquid in the bladder for 90 minutes.

Arm II: Patients undergo only surgery to remove bladder tumors.

Patients with T1 or Tis disease may receive BCG therapy once weekly for 6 weeks, followed by 6 weeks of rest.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: This study will accrue approximately 300 patients.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically diagnosed stage 0 (Ta), stage I, or recurrent superficial transitional cell carcinoma of the bladder; Must have at least 2 papillary appearing bladder tumors by cystoscopic examination
• Patients with recurrent disease must have no history of Tis tumor

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent biological response modifiers for bladder cancer
• Chemotherapy: No prior or concurrent chemotherapy for bladder cancer; No prior AD 32 therapy for bladder cancer
• Endocrine therapy: Not specified
• Radiotherapy: No prior or concurrent radiotherapy
• Surgery: At least 9 months since any complete transurethral resection of the bladder

--Patient Characteristics--

• Age: 18 and over
• Performance status: SWOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC greater than 4000/mm3; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); SGOT no greater than 2 times ULN
• Renal: Creatinine no greater than 2 times ULN
• Other: Not pregnant or nursing; Fertile patients must use effective contraception

Alabama
      Urology Associates, Birmingham,  Alabama,  35205,  United States
Arizona
      Urology Associates, Ltd., Phoenix,  Arizona,  85012,  United States
California
      Hillcrest Urological Medical Group, San Diego,  California,  92103,  United States
      San Diego Urology Center, San Diego,  California,  92120,  United States
      San Diego Urology Center, La Mesa,  California,  91942,  United States
      Santa Monica Urologic Medical Group, Santa Monica,  California,  90404,  United States
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
      Western Urological Associates, Van Nuys,  California,  91405,  United States
Connecticut
      Urology Specialists, P.C., Waterbury,  Connecticut,  06708,  United States
District of Columbia
      George Washington University Hospital, Washington,  District of Columbia,  20037,  United States
Florida
      Atlantic Urological Associates, Daytona Beach,  Florida,  32114,  United States
      Office of Ira W. Klimberg, Ocala,  Florida,  32674,  United States
      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States
      University of Florida - Gainesville, Gainesville,  Florida,  32610-0277,  United States
      Urology Care - South, Miami,  Florida,  33173,  United States
      Urology Health Center, New Port Richey,  Florida,  34652,  United States
      Urology Treatment Center, Sarasota,  Florida,  3429,  United States
Georgia
      Georgia Urology, Atlanta,  Georgia,  30342,  United States
Illinois
      Affliated Urology, Chicago,  Illinois,  60612,  United States
      Evanston Northwestern Healthcare, Evanston,  Illinois,  60201,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Kentucky
      Clinic of Urologic Wellness, Lexington,  Kentucky,  40509,  United States
Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States
Massachusetts
      Cambridge Urological Associates, Inc., Cambridge,  Massachusetts,  02238,  United States
Michigan
      Michigan Institute of Urology, Detroit,  Michigan,  48236,  United States
Mississippi
      Mississippi Urology Clinic, P.A., Jackson,  Mississippi,  39202,  United States
Nebraska
      Urology Center, Omaha,  Nebraska,  68122,  United States
Nevada
      Desert Urology, North Las Vegas,  Nevada,  89128,  United States
      Sheldon Freedman Ltd., Las Vegas,  Nevada,  89109,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States
New Jersey
      Veterans Affairs Medical Center - East Orange, East Orange,  New Jersey,  07018-1095,  United States
New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      Office of John Byrne, New Rochelle,  New York,  10801,  United States
North Carolina
      Wake Urological Associates, Raleigh,  North Carolina,  27607,  United States
Ohio
      Department of Urology and Urologic Oncology, Columbus,  Ohio,  43210,  United States
Oregon
      Oregon Cancer Center at Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States
      Urology Clinic, P.C., Portland,  Oregon,  97210,  United States
Pennsylvania
      Office of Jeffrey K. Cohen, Pittsburgh,  Pennsylvania,  15222,  United States
Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
      Urology Associates of North Texas, Arlington,  Texas,  76015,  United States
      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States
      Wilford Hall - 59th Medical Wing, Lackland Air Force Base,  Texas,  78236-5300,  United States
Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84132,  United States
Virginia
      Sentara Cancer Center, Norfolk,  Virginia,  23507,  United States
      Virginia Urology Center, Richmond,  Virginia,  23230,  United States
Washington
      Office of Ronald G. Anderson, Tacoma,  Washington,  98405,  United States
West Virginia
      West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9162,  United States
Canada, Ontario
      Ottawa General Hospital, Ottawa,  Ontario,  K1H 8L6,  Canada
      Toronto General Hospital, Toronto,  Ontario,  M5G 2C4,  Canada

Study chairs or principal investigators

Peter R. Carroll,  Study Chair,  Anthra Pharmaceuticals   

Study ID Numbers:  CDR0000066837; ANTHRA-A9601
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003725
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08