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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
Open (Enrolling)
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:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Peter R. Carroll, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




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



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