Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
NCT ID: NCT02343614
Last Updated: 2015-01-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
58 participants
Study Classification
INTERVENTIONAL
Study Start Date
2003-03-31
Study Completion Date
2014-01-31
Brief Summary
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The treatment of non-muscle invasive bladder cancer (NMIBC) is problematic given the variable natural history of the disease. Although contemporary treatment options are limited, new targets and new approaches are under investigation for preventing bladder cancer recurrence and progression. Among those, COX-2 is a promising target since plays an important role in urothelial carcinogenesis and iCOX-2 selective inhibitors, like celecoxib, effectively inhibit tumor development and growth and enhances survival, in bladder cancer in vitro and in vivo models.
Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.
Therefore, the investigators conducted a pilot study of celecoxib to prevent recurrence in patients with intermediate risk NMIBC.
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Detailed Description
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Conditions
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Non Muscle Invasive Bladder Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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ARM A
Patients undergoing treatment with oral celecoxib
Group Type
EXPERIMENTAL
Celecoxib
Intervention Type
DRUG
Interventions
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Celecoxib
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Histologically proven urothelial bladder cancer
* Intermediate risk NMIBC
* ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
* Imaging study excluding upper urinary tract TCC
* Intermediate risk NMIBC
* ECOG Performance Status ≤ 2 or Karnofsky Score ≥ 60%
* Imaging study excluding upper urinary tract TCC
Exclusion Criteria
* Pregnant and lactating women;
* Advanced co-existing medical or psychiatric disorders;
* Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
* History of allergy to sulfonamide drugs;
* Concomitant investigational medications.
* Advanced co-existing medical or psychiatric disorders;
* Positive history of gastro-intestinal disease (peptic ulcer, inflammatory disease), intestinal bleeding;
* History of allergy to sulfonamide drugs;
* Concomitant investigational medications.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Sponsor Role
lead
Responsible Party
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Pagliarulo Vincenzo
Medical Doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Vincenzo VP Pagliarulo, Medical Doctor
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
References
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Arber N, Eagle CJ, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95. doi: 10.1056/NEJMoa061652.
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Colombel M, Saint F, Chopin D, Malavaud B, Nicolas L, Rischmann P. The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study. J Urol. 2006 Sep;176(3):935-9. doi: 10.1016/j.juro.2006.04.104.
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BACKGROUND
Dovedi SJ, Kirby JA, Davies BR, Leung H, Kelly JD. Celecoxib has potent antitumour effects as a single agent and in combination with BCG immunotherapy in a model of urothelial cell carcinoma. Eur Urol. 2008 Sep;54(3):621-30. doi: 10.1016/j.eururo.2008.01.013. Epub 2008 Jan 15.
Reference Type
BACKGROUND
Grubbs CJ, Lubet RA, Koki AT, Leahy KM, Masferrer JL, Steele VE, Kelloff GJ, Hill DL, Seibert K. Celecoxib inhibits N-butyl-N-(4-hydroxybutyl)-nitrosamine-induced urinary bladder cancers in male B6D2F1 mice and female Fischer-344 rats. Cancer Res. 2000 Oct 15;60(20):5599-602.
Reference Type
BACKGROUND
Kilbridge KL, Kantoff P. Intravesical therapy for superficial bladder cancer: is it a wash? J Clin Oncol. 1994 Jan;12(1):1-4. doi: 10.1200/JCO.1994.12.1.1. No abstract available.
Reference Type
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Klein RD, Van Pelt CS, Sabichi AL, Dela Cerda J, Fischer SM, Furstenberger G, Muller-Decker K. Transitional cell hyperplasia and carcinomas in urinary bladders of transgenic mice with keratin 5 promoter-driven cyclooxygenase-2 overexpression. Cancer Res. 2005 Mar 1;65(5):1808-13. doi: 10.1158/0008-5472.CAN-04-3567.
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Koya MP, Simon MA, Soloway MS. Complications of intravesical therapy for urothelial cancer of the bladder. J Urol. 2006 Jun;175(6):2004-10. doi: 10.1016/S0022-5347(06)00264-3.
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Reference Type
BACKGROUND
Phillips RK, Wallace MH, Lynch PM, Hawk E, Gordon GB, Saunders BP, Wakabayashi N, Shen Y, Zimmerman S, Godio L, Rodrigues-Bigas M, Su LK, Sherman J, Kelloff G, Levin B, Steinbach G; FAP Study Group. A randomised, double blind, placebo controlled study of celecoxib, a selective cyclooxygenase 2 inhibitor, on duodenal polyposis in familial adenomatous polyposis. Gut. 2002 Jun;50(6):857-60. doi: 10.1136/gut.50.6.857.
Reference Type
BACKGROUND
Ristimaki A, Nieminen O, Saukkonen K, Hotakainen K, Nordling S, Haglund C. Expression of cyclooxygenase-2 in human transitional cell carcinoma of the urinary bladder. Am J Pathol. 2001 Mar;158(3):849-53. doi: 10.1016/S0002-9440(10)64033-3.
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BACKGROUND
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BACKGROUND
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Reference Type
BACKGROUND
Solomon SD, McMurray JJ, Pfeffer MA, Wittes J, Fowler R, Finn P, Anderson WF, Zauber A, Hawk E, Bertagnolli M; Adenoma Prevention with Celecoxib (APC) Study Investigators. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med. 2005 Mar 17;352(11):1071-80. doi: 10.1056/NEJMoa050405. Epub 2005 Feb 15.
Reference Type
BACKGROUND
Steinbach G, Lynch PM, Phillips RK, Wallace MH, Hawk E, Gordon GB, Wakabayashi N, Saunders B, Shen Y, Fujimura T, Su LK, Levin B, Godio L, Patterson S, Rodriguez-Bigas MA, Jester SL, King KL, Schumacher M, Abbruzzese J, DuBois RN, Hittelman WN, Zimmerman S, Sherman JW, Kelloff G. The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med. 2000 Jun 29;342(26):1946-52. doi: 10.1056/NEJM200006293422603.
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BACKGROUND
Sylvester RJ, van der Meijden AP, Oosterlinck W, Witjes JA, Bouffioux C, Denis L, Newling DW, Kurth K. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006 Mar;49(3):466-5; discussion 475-7. doi: 10.1016/j.eururo.2005.12.031. Epub 2006 Jan 17.
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van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR. Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol. 2009 Sep;56(3):430-42. doi: 10.1016/j.eururo.2009.06.028. Epub 2009 Jun 26.
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Witjes JA, Hendricksen K. Intravesical pharmacotherapy for non-muscle-invasive bladder cancer: a critical analysis of currently available drugs, treatment schedules, and long-term results. Eur Urol. 2008 Jan;53(1):45-52. doi: 10.1016/j.eururo.2007.08.015. Epub 2007 Aug 20.
Reference Type
BACKGROUND
Other Identifiers
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2401
Identifier Type: -
Identifier Source: org_study_id
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