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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

Phase 3
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

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



- 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

- Compare the qualitative and quantitative toxicities of these regimens in these

- 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.

Inclusion Criteria


- Diagnosis of newly diagnosed or recurrent transitional cell bladder cancer meeting
the following criteria:

- Ta or T1 primary tumor

- Grade 1 or 2 disease

- No more than 2 recurrences (except for index tumor) within the 18 months prior to the
index tumor's transurethral resection of the bladder tumor (TURBT)

- Index tumor post-TURBT must meet the following criteria:

- Ta or T1 tumor without any prior tumor in situ, grade 3 (high grade)
disease within 2 years prior to index tumor TURT, or invasion of the
muscularis propria (stage ≥ T2)

- Grade 1 or 2 disease (similar to papillary urothelial neoplasm of low
malignant potential and low-grade bladder cancer)

- Not a candidate for a therapy other than TURBT (e.g., a series of instillations of
intravesical immunotherapy [e.g., BCG] or intravesical chemotherapy, or cystectomy or
partial cystectomy)

- Negative upper tract imaging studies within 1 year (365 days) prior to study entry

- Imaging studies may be performed after registration provided it is done prior to
TURBT on the day of treatment

- No urothelial cancer of the prostate or more distal urethra (or urethra at all in
women) as assessed by endoscopy

- Must have a negative urine culture (less than or equal to 10,000 col/mL, mixed
flora-likely contamination) OR negative urine analysis for infection AND negative
nitrates on reagent strip, ≤ 10 WBC/high-power field, and no rods or organisms on
examination of spun urine sediment OR an automated or visual reagent strip urinalysis
that is negative for leukocytes and nitrates within the past 28 days

- TURBT planned within the next 28 days and planned treatment within 3 hours after


- Zubrod performance status 0-1

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other prior malignancy except for any of the following:

- Adequately treated basal cell or squamous cell skin cancer

- In situ cervical cancer

- Adequately treated stage I or II cancer from which patient is in complete

- Any other cancer from which patient has been disease-free for 3 years


- See Disease Characteristics

- More than 145 days since prior intravesical therapy

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Time to recurrence

Safety Issue:


Principal Investigator

Edward M. Messing, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2007

Completion Date:

Related Keywords:

  • Bladder Cancer
  • transitional cell carcinoma of the bladder
  • stage 0 bladder cancer
  • stage I bladder cancer
  • recurrent bladder cancer
  • Urinary Bladder Neoplasms



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