S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
- Registration Number
- NCT00445601
- Lead Sponsor
- SWOG Cancer Research Network
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I gemcitabine hydrochloride Patients receive intravesical gemcitabine hydrochloride over 1 hour. Arm II placebo Patients receive intravesical placebo over 1 hour.
- Primary Outcome Measures
Name Time Method Disease Recurrence Rate Up to 2 Years Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.
- Secondary Outcome Measures
Name Time Method Rate of Disease Worsening Over 2 Years Up to 2 years 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.
Rate of Progression to Muscle Invasive Disease at 4 Years 4 years From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT) Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug
Trial Locations
- Locations (70)
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Good Samaritan Cancer Center
🇺🇸Puyallup, Washington, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Medical Oncology at KRMC
🇺🇸Kalispell, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Mount Carmel Regional Cancer Center
🇺🇸Pittsburg, Kansas, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Centers - North
🇺🇸Kansas City, Missouri, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
St. James Healthcare Cancer Care
🇺🇸Butte, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Bay Area Hospital
🇺🇸Coos Bay, Oregon, United States
Veterans Affairs Medical Center - Houston
🇺🇸Houston, Texas, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
St. Joseph Regional Medical Center
🇺🇸Lewiston, Idaho, United States
Kansas City Cancer Centers - West
🇺🇸Kansas City, Kansas, United States
St. Rose Ambulatory and Surgery Center
🇺🇸Great Bend, Kansas, United States
Hays Medical Center
🇺🇸Hays, Kansas, United States
Kansas City Cancer Centers - Southwest
🇺🇸Overland Park, Kansas, United States
Kansas City Cancer Center - Shawnee Mission
🇺🇸Shawnee Mission, Kansas, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸Shreveport, Louisiana, United States
Kansas City Cancer Centers - South
🇺🇸Kansas City, Missouri, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Cancer Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Urology Center of Colorado
🇺🇸Denver, Colorado, United States
Veterans Affairs Medical Center - Denver
🇺🇸Denver, Colorado, United States
Knight Cancer Institute at Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University Hospital - San Antonio
🇺🇸San Antonio, Texas, United States
Hutchinson Hospital Corporation
🇺🇸Hutchinson, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Truman Medical Center - Hospital Hill
🇺🇸Kansas City, Missouri, United States
Kansas City Cancer Centers - East
🇺🇸Lee's Summit, Missouri, United States
Northern Montana Hospital
🇺🇸Havre, Montana, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Wilford Hall Medical Center
🇺🇸Lackland Air Force Base, Texas, United States
Overlake Cancer Center at Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
Providence Centralia Hospital
🇺🇸Centralia, Washington, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
🇺🇸Tacoma, Washington, United States
Providence Regional Cancer Partnership
🇺🇸Everett, Washington, United States
Franciscan Cancer Center at St. Joseph Medical Center
🇺🇸Tacoma, Washington, United States
Providence St. Peter Hospital Regional Cancer Center
🇺🇸Olympia, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Madigan Army Medical Center - Tacoma
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States