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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



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