[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100064133":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":19,"centralContacts":7,"locations":7,"responsibleParty":23,"collaborators":25,"id":29,"slug":30,"hasResults":31,"nctId":32,"briefTitle":33,"officialTitle":34,"acronym":7,"eligibilityCriteria":35,"healthyVolunteers":31,"sex":36,"minAge":37,"maxAge":7,"enrollmentInfo":38,"targetDuration":7,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":54,"whyStopped":55,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":7},{"fullName":5,"class":6},"Fox Chase Cancer Center","OTHER",null,[9,12,14,17],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","celecoxib",{"type":10,"name":13,"description":7,"armGroupLabels":7,"otherNames":7},"rosiglitazone maleate",{"type":15,"name":16,"description":7,"armGroupLabels":7,"otherNames":7},"PROCEDURE","conventional surgery",{"type":15,"name":18,"description":7,"armGroupLabels":7,"otherNames":7},"neoadjuvant therapy",[20],{"name":21,"affiliation":5,"role":22},"Nancy Lewis, MD","PRINCIPAL_INVESTIGATOR",{"type":24,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[26],{"name":27,"class":28},"National Cancer Institute (NCI)","NIH","100064133","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-100064133",false,"NCT00084578","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","DISEASE CHARACTERISTICS:\n\n* Histologically and clinically confirmed bladder cancer\n\n  * Cohort 1\n\n    * Papillary transitional cell carcinoma of the urinary bladder\n\n      * Stage Ta or T1 (grade 1 or 2), N0, M0 disease\n      * Must have undergone complete transurethral resection of the bladder within the past 28 days AND\u002FOR\n    * Carcinoma in situ of the urinary bladder\n\n      * Stage Tis, N0, M0 disease\n      * Must have undergone biopsy within the past 28 days\n    * No histological and pathological evidence of invasion of the underlying muscle (stage T2)\n  * Cohort 2\n\n    * Muscle-invasive papillary transitional cell carcinoma of the urinary bladder\n    * Stage T2-4, NX, M0 disease\n    * Intending to undergo radical cystectomy\n    * 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\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC \\> 4,000\u002Fmm\\^3\n* Platelet count \\> 100,000\u002Fmm\\^3\n\nHepatic\n\n* Bilirubin \\\u003C 2 times upper limit of normal (ULN)\n* SGOT and SGPT \\\u003C 3 times ULN\n\nRenal\n\n* Creatinine ≤ 2.5 mg\u002FdL\n\nOther\n\n* 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\n* No history of uncontrolled peptic ulcer disease\n* No history of unexplained hypoglycemia\n* No known sensitivity to celecoxib or rosiglitazone\n* No allergy to sulfonamides\n* No history of asthma, urticaria, or allergic reaction after taking aspirin or other NSAIDs\n* No underlying uncontrolled medical illness\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* At least 3 months since prior intravesical BCG\n\nChemotherapy\n\n* No prior intravesical or systemic chemotherapy\n\nEndocrine therapy\n\n* No concurrent insulin\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* 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\n* No concurrent beta-blockers\n* No concurrent NSAIDs\n* No other concurrent oral hypoglycemic agents","ALL","18 Years",{"count":39,"type":40},0,"ACTUAL","INTERVENTIONAL",[43],"NA","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.\n\nPURPOSE: 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.",[46],"Bladder Cancer",[48,49,50,51,52,53],"stage 0 bladder cancer","stage I bladder cancer","stage II bladder cancer","stage III bladder cancer","stage IV bladder cancer","transitional cell carcinoma of the bladder","WITHDRAWN","Withdrawn due to drug toxicity","2013-07-12",{"date":58,"type":59},"2013-07-15","ESTIMATED",{"date":61,"type":7},"2004-03",{"date":63,"type":40},"2006-04",{"name":5,"class":6}]