Status:
WITHDRAWN
Celecoxib and Rosiglitazone in Treating Patients Who Are Undergoing Cystoscopic Surveillance for Early-Stage Noninvasive Carcinoma of the Bladder or Radical Cystectomy for Muscle-Invasive Carcinoma of the Bladder
Lead Sponsor:
Fox Chase Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Rosiglitazone may help tumor cells develop into norm...
Detailed Description
OBJECTIVES: Primary * Determine whether rosiglitazone and celecoxib, administered alone or in combination, cause changes in the expression of effector molecules, peroxisome proliferator-activated re...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically and clinically confirmed bladder cancer
- Cohort 1
- Papillary transitional cell carcinoma of the urinary bladder
- Stage Ta or T1 (grade 1 or 2), N0, M0 disease
- Must have undergone complete transurethral resection of the bladder within the past 28 days AND/OR
- Carcinoma in situ of the urinary bladder
- Stage Tis, N0, M0 disease
- Must have undergone biopsy within the past 28 days
- No histological and pathological evidence of invasion of the underlying muscle (stage T2)
- Cohort 2
- Muscle-invasive papillary transitional cell carcinoma of the urinary bladder
- Stage T2-4, NX, M0 disease
- Intending to undergo radical cystectomy
- Must have had an upper tract (ureter and renal pelvic) evaluation by intravenous pyelogram, CT scan, or MRI that proved normal within the past year
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- WBC \> 4,000/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 2 times upper limit of normal (ULN)
- SGOT and SGPT \< 3 times ULN
- Renal
- Creatinine ≤ 2.5 mg/dL
- Other
- No other malignancy within the past 3 years except non-invasive bladder cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix
- No history of uncontrolled peptic ulcer disease
- No history of unexplained hypoglycemia
- No known sensitivity to celecoxib or rosiglitazone
- No allergy to sulfonamides
- No history of asthma, urticaria, or allergic reaction after taking aspirin or other NSAIDs
- No underlying uncontrolled medical illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 3 months since prior intravesical BCG
- Chemotherapy
- No prior intravesical or systemic chemotherapy
- Endocrine therapy
- No concurrent insulin
- Radiotherapy
- Not specified
- Surgery
- See Disease Characteristics
- Other
- At least 2 weeks since prior use of non-steroidal anti-inflammatory drugs (NSAIDs) (including COX-2 inhibitors) for more than 3 consecutive days except low-dose (81 mg) aspirin
- No concurrent beta-blockers
- No concurrent NSAIDs
- No other concurrent oral hypoglycemic agents
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00084578
Start Date
March 1 2004
End Date
April 1 2006
Last Update
July 15 2013
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