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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
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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
TURBT

PATIENT CHARACTERISTICS:

- 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
remission

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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 145 days since prior intravesical therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to recurrence

Safety Issue:

No

Principal Investigator

Edward M. Messing, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000534235

NCT ID:

NCT00445601

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

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - DenverDenver, Colorado  80220
Veterans Affairs Medical Center - Kansas CityKansas City, Missouri  64128
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - HoustonHouston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy)San Antonio, Texas  78284
CCOP - NorthwestTacoma, Washington  98405-0986
University of California Davis Cancer CenterSacramento, California  95817
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Madigan Army Medical Center - TacomaTacoma, Washington  98431
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Feist-Weiller Cancer Center at Louisiana State University Health SciencesShreveport, Louisiana  71130-3932
Cancer Therapy and Research CenterSan Antonio, Texas  78229
University Hospital - San AntonioSan Antonio, Texas  78229
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Truman Medical Center - Hospital HillKansas City, Missouri  64108
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Methodist HospitalHouston, Texas  77030
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Bay Area HospitalCoos Bay, Oregon  97420
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Mount Carmel Regional Cancer CenterPittsburg, Kansas  66762
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Hays Medical CenterHays, Kansas  67601
Hutchinson Hospital CorporationHutchinson, Kansas  67502
Overlake Cancer Center at Overlake Hospital Medical CenterBellevue, Washington  98004
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
St. Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Kansas City Cancer Centers - WestKansas City, Kansas  66112
Kansas City Cancer Center - Shawnee MissionShawnee Mission, Kansas  66204
Kansas City Cancer Centers - EastLee's Summit, Missouri  64064
Providence Regional Cancer PartnershipEverett, Washington  98201
Urology Center of ColoradoDenver, Colorado  80211
St. Joseph Regional Medical CenterLewiston, Idaho  83501