S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
|ClinicalTrials.gov Identifier: NCT00445601|
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : October 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: gemcitabine hydrochloride Other: placebo||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||371 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||September 2007|
|Primary Completion Date :||September 2016|
|Study Completion Date :||September 2016|
U.S. FDA Resources
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.
- Time to recurrence [ Time Frame: up to 2 years ]Measured from date of registration to date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence are censored at the time of their last cystoscopy. Patients who die without any evidence of disease recurrence, will be censored at time of death.
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: up to 4 weeks after Transurethral Resection of Bladder Tumor (TURBT) ]Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
- Worsening-free survival [ Time Frame: Up to 4 years ]Measured from date of registration to date of first observation of subsequently confirmed recurrent disease, progression, start of systemic chemotherapy, radiation or cystectomy, or death due to any cause. Patients who experience none of these events will be censored at date of last disease assessment.
- Sensitivity and specificity of BTA Stat test the NMP-22 Bladder Chek alone and in combination [ Time Frame: Up to 2 years ]Evaluate whether performing a combination of molecular/cytologic diagnostic marker tests including NMP-22 Bladder Chek and BTA Stat every three months can predict recurrence as accurately as cystoscopy alone. BTA Stat and NMP-22 Bladder Chek will each be performed prior to the TURBT of the index tumor and with each surveillance cystoscopy for 2 years, or until first histologically confirmed recurrence (whichever is sooner).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445601
Show 70 Study Locations
|Study Chair:||Edward M. Messing, MD, FACS||James P. Wilmot Cancer Center|
|Study Chair:||Deepak M. Sahasrabudhe, MD||James P. Wilmot Cancer Center|
|Study Chair:||Theresa M. Koppie, MD||Oregon Health and Science University|
|Study Chair:||David P. Wood, MD||Beaumont Physician Partners|