Phase II Study of Intravesical Gemcitabine in Patients With Superficial Bladder Cancer Who Have Progressed Despite Intravesical BCG

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