Status:
COMPLETED
S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
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 ...
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 pre...
Eligibility Criteria
Inclusion
- 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 TURBT, 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 white blood cell count (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
Exclusion
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00445601
Start Date
September 1 2007
End Date
June 1 2017
Last Update
January 18 2020
Active Locations (70)
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1
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of California Davis Cancer Center
Sacramento, California, United States, 95817
4
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045