S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed superficial transitional cell carcinoma (TCC) of the bladder meeting 1 of the following stage criteria:
• •* Stage T1, grade 2-3
• •* Stage Tis
• •* Stage Ta, grade 3-4 or multifocal (\> 2 lesions)
• •Must have received and failed ≥ 2 courses of intravesical Bacillus Calmette-Guerin (BCG) (one 6-week course, plus one 3-week course, or fewer weeks if BCG was discontinued due to side effects) within the past 3 years
• •Recurrent disease
• •* Must have had a transurethral resection of the bladder tumor (TURBT) or bladder biopsy within the past 60 days documenting tumor recurrence and tumor stage and grade
• •* TURBT or biopsy must have been performed ≥ 6 weeks after the completion of BCG and/or other immunotherapy treatment (or ≥ 14 days after completion of intravesical chemotherapy treatment)
• •* All visible tumor must have been resected at the time of the last biopsy
• •No evidence of urethral or renal pelvis TCC by upper tract radiological imaging (e.g., intravenous pyelogram, CT urogram, or retrograde pyelogram) within the past 2 years
• •PATIENT CHARACTERISTICS:
• •Age
• •18 and over
• •Performance status
• •Zubrod 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Not specified
• •Hepatic
• •Not specified
• •Renal
• •Not specified
• •Other
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •See Disease Characteristics
• •Prior intravesical interferon alfa allowed, alone or in combination with Bacillus Calmette-Guerin (BCG)
• •Chemotherapy
• •See Disease Characteristics
• •No more than 1 course of intravesical chemotherapy (e.g., thiotepa, mitomycin, or doxorubicin) within the past year, defined as 6 or more weekly instillations, with or without monthly maintenance instillations
• •No prior gemcitabine
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •No prior pelvic radiotherapy
• •No concurrent radiotherapy to any other area of the body
• •Surgery
• •See Disease Characteristics
• •Recovered from prior surgery