S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of a single intravesical instillation of gemcitabine hydrochloride
           vs placebo immediately after transurethral resection of the bladder tumor (TURBT) in
           preventing recurrence at 2 years in patients with grade 1 or 2 superficial transitional
           cell cancer of the bladder.

      Secondary

        -  Compare whether a single instillation of intravesical gemcitabine hydrochloride can
           improve the time to progression to muscle invasive disease vs placebo in these patients.

        -  Compare the qualitative and quantitative toxicities of these regimens in these patients.

        -  Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs
           placebo results in reduced long-term morbidity in patients, as defined by requirement
           for fewer TURBTs, courses of traditional intravesical therapies, and surveillance
           cystoscopies over 4 years.

      Tertiary

        -  Assess whether performing a combination of molecular and/or cytologic diagnostic marker
           tests, including NMP-22 Bladder Chek and BTA Stat every 3 months, can predict recurrence
           as accurately as cystoscopy alone in these patients.

      OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
      according to disease status (first occurrence vs recurrent disease) and number of tumor sites
      (1 vs ≥ 2). Patients are randomized to 1 of 2 treatment arms.

      All patients undergo transurethral resection of the bladder tumor. Within 3 hours, patients
      receive intravesical therapy according to their randomized arm.

        -  Arm I: Patients receive intravesical gemcitabine hydrochloride over 1 hour.

        -  Arm II: Patients receive intravesical placebo over 1 hour. Urine is collected at
           baseline and then every 3 months for 2 years for research studies including the NMP-22
           Bladder Chek and BTA Stat test.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 2 years.

      PROJECTED ACCRUAL: A total of 340 patients will be accrued for this study.
    

Intervention name(s): gemcitabine hydrochloride; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given intravesically; Given intravesically
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transitional cell carcinoma of the bladder; stage 0 bladder cancer; stage I bladder cancer; recurrent bladder cancer