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Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-Valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

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Trial Information

Phase III Randomized Study of a Single Adjunctive Instillation of Intravesical AD 32 (N-Trifluoroacetyladriamycin-14-Valerate) Versus No Adjunctive Therapy Immediately Following Transurethral Resection in Patients With Multiple Superficial (Ta/T1) Bladder Tumors


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.

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.

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Peter R. Carroll, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000066837

NCT ID:

NCT00003725

Start Date:

December 1996

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

Baylor College of MedicineHouston, Texas  77030
University of Chicago Cancer Research CenterChicago, Illinois  60637
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
Mount Sinai Medical Center, NYNew York, New York  10029
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - TempleTemple, Texas  76504
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
George Washington University HospitalWashington, District of Columbia  20037
Urology Specialists, P.C.Waterbury, Connecticut  06708
University of Florida - GainesvilleGainesville, Florida  32610-0277
Urology AssociatesBirmingham, Alabama  35205
Urology Associates, Ltd.Phoenix, Arizona  85012
San Diego Urology CenterLa Mesa, California  91942
Hillcrest Urological Medical GroupSan Diego, California  92103
Santa Monica Urologic Medical GroupSanta Monica, California  90404
Western Urological AssociatesVan Nuys, California  91405
Atlantic Urological AssociatesDaytona Beach, Florida  32114
Urology Care - SouthMiami, Florida  33173
Urology Health CenterNew Port Richey, Florida  34652
Office of Ira W. KlimbergOcala, Florida  32674
Urology Treatment CenterSarasota, Florida  3429
Georgia UrologyAtlanta, Georgia  30342
Affliated UrologyChicago, Illinois  60612
Evanston Northwestern HealthcareEvanston, Illinois  60201
Clinic of Urologic WellnessLexington, Kentucky  40509
Cambridge Urological Associates, Inc.Cambridge, Massachusetts  02238
Michigan Institute of UrologyDetroit, Michigan  48236
Mississippi Urology Clinic, P.A.Jackson, Mississippi  39202
Urology CenterOmaha, Nebraska  68122
Sheldon Freedman Ltd.Las Vegas, Nevada  89109
Desert UrologyNorth Las Vegas, Nevada  89128
Office of John ByrneNew Rochelle, New York  10801
Wake Urological AssociatesRaleigh, North Carolina  27607
Department of Urology and Urologic OncologyColumbus, Ohio  43210
Urology Clinic, P.C.Portland, Oregon  97210
Office of Jeffrey K. CohenPittsburgh, Pennsylvania  15222
Urology Associates of North TexasArlington, Texas  76015
Sentara Cancer CenterNorfolk, Virginia  23507
Virginia Urology CenterRichmond, Virginia  23230
Office of Ronald G. AndersonTacoma, Washington  98405