S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: gemcitabine hydrochloride
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent bladder cancer; stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder

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 may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with
      recurrent bladder cancer that has progressed despite previous Bacillus Calmette-Guerin (BCG).
    

Eligibility 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