Phase II Study of Intravesical Therapy With AD 32 in Patients With Papillary Urothelial Carcinoma or Carcinoma in Situ (CIS) Refractory to Prior Therapy With Bacillus Calmette-Guerin

Date de début de l'étude : 1 septembre 1998

DISEASE CHARACTERISTICS: Histologically confirmed recurrent superficial bladder cancer defined as papillary transitional cell carcinoma (stage Ta/T1) and/or carcinoma in situ (stage Tis) of the urinary bladder No evidence of invasion of the underlying muscle (stage T2) at baseline Must meet 1 of the following criteria: Failure of at least 2 prior courses of intravesical therapy, 1 of which must have been a course of BCG Recurrent or persistent disease within 6 months after failing a 6-week course of BCG followed by maintenance therapy Inability or ineligibility to complete 1 course of intravesical therapy with BCG, and failure of 2 prior courses of intravesical therapy with an alternative agent Diagnosis must have been made no more than 24 months after completion of prior treatment with intravesical immunotherapy or chemotherapy If carcinoma in situ is current or previous diagnosis, the biopsies must be obtained from at least 4 sites (bladder mapping) If prostatic urothelial biopsy discloses carcinoma in situ, transurethral prostatic resection must be carried out prior to study Papillary disease must have undergone complete transurethral resection (TURBT) within 28 days before study PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT and SGPT less than 3 times ULN Renal: Creatinine no greater than 2.5 mg/dL Other: Normal upper tract (ureter and renal pelvic) evaluation within 6 months No known sensitivity to anthracyclines or to Cremophor EL HIV negative No known AIDS or HIV-1 associated complex No other significant concurrent illness No other prior malignancy within the past 3 years except superficial bladder cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No concurrent biological response modifier therapy Chemotherapy: See Disease Characteristics Prior oral bropirimine for bladder cancer allowed No prior AD 32 for bladder cancer No other intravenously administered systemic chemotherapy for bladder cancer No concurrent chemotherapy for any other malignancy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: No prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics