Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2013

Interventions

  • Drug: Celecoxib

Arms, Groups and Cohorts

  • Experimental: ARM A
    • Patients undergoing treatment with oral celecoxib

Clinical Trial Outcome Measures

Primary Measures

  • Time to first recurrence
    • Time Frame: 5 years
  • Safety assessed by description of grade 1-4 adverse events
    • Time Frame: 5 years

Participating in This Clinical Trial

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 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pagliarulo Vincenzo, Medical Doctor – Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
  • Overall Official(s)
    • Vincenzo VP Pagliarulo, Medical Doctor, Principal Investigator, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

References

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