Chemotherapy in Treating Patients With Early-Stage Bladder Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of chemotherapy in treating patients with early-stage bladder cancer that has not responded to BCG therapy.

Detailed Description
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OBJECTIVES: Determine the recurrence rate and disease free survival in patients with recurrent or refractory papillary transitional cell carcinoma of the bladder with or without carcinoma in situ of the bladder treated with intravesical AD 32. Evaluate the safety of administering this drug in these patients. Determine the effectiveness of this drug, in terms of recurrence rates and disease free survival, in these patients. OUTLINE: Patients are stratified according to cellular diagnosis (papillary transitional cell carcinoma (Ta/T1) with no carcinoma in situ (Tis) vs Tis with or without Ta/T1). Patients receive intravesical AD 32 once a week for 6 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Official Title
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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

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: valrubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: valrubicin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder