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

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.