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
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.
Interventional
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Time to recurrence
No
Edward M. Messing, MD, FACS
Study Chair
James P. Wilmot Cancer Center
United States: Federal Government
CDR0000534235
NCT00445601
September 2007
Name | Location |
---|---|
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Veterans Affairs Medical Center - Denver | Denver, Colorado 80220 |
Veterans Affairs Medical Center - Kansas City | Kansas City, Missouri 64128 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Veterans Affairs Medical Center - Houston | Houston, Texas 77030 |
Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio, Texas 78284 |
CCOP - Northwest | Tacoma, Washington 98405-0986 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
Cancer Therapy and Research Center | San Antonio, Texas 78229 |
University Hospital - San Antonio | San Antonio, Texas 78229 |
St. Francis Hospital | Federal Way, Washington 98003 |
St. Clare Hospital | Lakewood, Washington 98499-0998 |
Providence St. Peter Hospital Regional Cancer Center | Olympia, Washington 98506 |
Good Samaritan Cancer Center | Puyallup, Washington 98371 |
Allenmore Hospital | Tacoma, Washington 98411-0414 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
St. James Healthcare Cancer Care | Butte, Montana 59701 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Northern Montana Hospital | Havre, Montana 59501 |
Kalispell Medical Oncology at KRMC | Kalispell, Montana 59901 |
Providence Centralia Hospital | Centralia, Washington 98531-9027 |
Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
Methodist Hospital | Houston, Texas 77030 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Bay Area Hospital | Coos Bay, Oregon 97420 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Mount Carmel Regional Cancer Center | Pittsburg, Kansas 66762 |
Kansas City Cancer Centers - Southwest | Overland Park, Kansas 66210 |
Hays Medical Center | Hays, Kansas 67601 |
Hutchinson Hospital Corporation | Hutchinson, Kansas 67502 |
Overlake Cancer Center at Overlake Hospital Medical Center | Bellevue, Washington 98004 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Kansas City Cancer Centers - South | Kansas City, Missouri 64131 |
St. Rose Ambulatory and Surgery Center | Great Bend, Kansas 67530 |
Kansas City Cancer Centers - West | Kansas City, Kansas 66112 |
Kansas City Cancer Center - Shawnee Mission | Shawnee Mission, Kansas 66204 |
Kansas City Cancer Centers - East | Lee's Summit, Missouri 64064 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Urology Center of Colorado | Denver, Colorado 80211 |
St. Joseph Regional Medical Center | Lewiston, Idaho 83501 |