Suspended

A Randomized Trial of Celecoxib and Rosiglitazone, Alone and in Combination, in Patients With Early Stage Non-Invasive Bladder Carcinoma Undergoing Cystoscopic Surveillance and in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy

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What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+11

+ Urinary Bladder Diseases
+ Urinary Bladder Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorFox Chase Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine whether rosiglitazone and celecoxib, administered alone or in combination, cause changes in the expression of effector molecules, peroxisome proliferator-activated receptor-γ (PPAR-γ) and cyclo-oxygenase-1 (COX-1), in patients with early-stage non-invasive carcinoma of the bladder undergoing cystoscopic surveillance or in patients with muscle-invasive carcinoma of the bladder undergoing radical cystectomy. Secondary * Determine whether these regimens result in changes in the expression of downstream effector molecules that mediate cellular proliferation and apoptosis in these patients. * Determine the relationship between tissue levels of biomarkers of drug effect, proliferation, and apoptosis and the systemic biomarkers of response to treatment, in terms of COX-2 activity and the levels of the endogenous PPAR-γ ligand, in patients treated with these regimens. * Determine the toxicity of these regimens in these patients. * Determine the frequency of recurrence and the time to progression in patients undergoing cystoscopic surveillance. OUTLINE: This is a randomized, pilot, cohort study. Patients are assigned to 1 of 2 cohorts according to disease stage (Ta, Tis, T1, N0, M0 vs T2-4, NX, M0). * Stage 1: * Cohort 1: Patients receive oral celecoxib twice daily and oral rosiglitazone once daily for 1 year in the absence of disease progression or unacceptable toxicity. * Cohort 2: Patients receive oral celecoxib twice daily and oral rosiglitazone once daily for 14 days. Patients then undergo cystectomy. * Stage 2: Patients are randomized into 1 of 2 treatment arms. * Arm I: * Cohort 1: Patients receive oral celecoxib twice daily for 1 year in the absence of disease progression or unacceptable toxicity. * Cohort 2: Patients receive oral celecoxib twice daily for 14 days. Patients then undergo cystectomy. * Arm II: * Cohort 1: Patients receive oral rosiglitazone once daily for 1 year in the absence of disease progression or unacceptable toxicity. * Cohort 2: Patients receive oral rosiglitazone once daily for 14 days. Patients then undergo cystectomy. Patients in cohort 1 (in both stages) undergo cystoscopic surveillance every 3 months. PROJECTED ACCRUAL: A total of 120 patients (20 per cohort in study stage 1; 40 per treatment arm \[20 per cohort in each arm\] in study stage 2) will be accrued for this study within 12-18 months.

Official TitleA Randomized Trial of Celecoxib and Rosiglitazone, Alone and in Combination, in Patients With Early Stage Non-Invasive Bladder Carcinoma Undergoing Cystoscopic Surveillance and in Patients With Muscle-Invasive Bladder Cancer Undergoing Radical Cystectomy 
NCT00084578
Principal SponsorFox Chase Cancer Center
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Carcinoma
Female Urogenital Diseases and Pregnancy Complications
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Female Urogenital Diseases
Male Urogenital Diseases
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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