A Phase III Blinded Study of Immediate Post-Turbt Instillation of Gemcitabine Versus Saline in Patients With Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting
the following criteria:

- Ta or T1 primary tumor

- Grade 1 or 2 disease

- No more than 2 recurrences (except for index tumor) within the 18 months prior to the
index tumor's transurethral resection of the bladder tumor (TURBT)

- Index tumor post-TURBT must meet the following criteria:

- Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade)
disease within 2 years prior to index tumor TURT, or invasion of the
muscularis propria (stage ≥ T2)

- Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low
malignant potential and low-grade bladder cancer)

- Not a candidate for a therapy other than TURBT (e.g., a series of instillations of
intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or
partial cystectomy)

- Negative upper tract imaging studies within 1 year (365 days) prior to study entry

- Imaging studies may be performed after registration provided it is done prior to
TURBT on the day of treatment

- No urothelial cancer of the prostate or more distal urethra (or urethra at all in
women) as assessed by endoscopy

- Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed
flora-likely contamination) OR negative urine analysis for infection AND negative
nitrates on reagent strip, ≤ 10 WBC/high-power field, and no rods or organisms on
examination of spun urine sediment OR an automated or visual reagent strip urinalysis
that is negative for leukocytes and nitrates within the past 28 days

- TURBT planned within the next 28 days and planned treatment within 3 hours after
TURBT

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer from which patient is in complete
remission

- Any other cancer from which patient has been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 145 days since prior intravesical therapy