Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to drug toxicity
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| rosiglitazone maleate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available