Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||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|
- Time to recurrence [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Worsening-free survival [ Designated as safety issue: No ]
- Sensitivity and specificity of BTA Stat test [ Designated as safety issue: No ]
- Sensitivity and specificity of NMP-22 Bladder Chek [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients receive intravesical gemcitabine hydrochloride over 1 hour.
Drug: gemcitabine hydrochloride
Placebo Comparator: Arm II
Patients receive intravesical placebo over 1 hour.
- 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.
- 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.
- 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.
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|Study Chair:||Edward M. Messing, MD, FACS||James P. Wilmot Cancer Center|
|Investigator:||David P. Wood, MD||Beaumont Physician Partners|