S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: gemcitabine hydrochloride; placebo
Intervention description: Given intravesically; Given intravesically
Intervention MeSH terms: Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 406.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: transitional cell carcinoma of the bladder; stage 0 bladder cancer; stage I bladder cancer; recurrent bladder cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is
      not yet known whether giving gemcitabine directly into the bladder is more effective than a
      placebo in treating bladder cancer.

      PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works
      when given directly into the bladder compared with a placebo after surgery in treating
      patients with newly diagnosed or recurrent bladder cancer.
    

Eligibility 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 TURBT, 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 white blood cell count (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