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

• Status: Withdrawn
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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 normal bladder cells.

PURPOSE: This randomized clinical trial is studying how well giving celecoxib together with rosiglitazone works in treating patients who are undergoing cystoscopic surveillance (screening) for early-stage noninvasive (carcinoma in situ) carcinoma (cancer) of the bladder or radical cystectomy for muscle-invasive carcinoma (cancer has spread into the muscle layer of bladder tissue) of the bladder.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fox Chase Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Celecoxib; Rosiglitazone

Criteria

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