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Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Primary Purpose

Non Muscle Invasive Bladder Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Muscle Invasive Bladder Cancer focused on measuring Intermediate risk, Cox-2 inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ARM A

    Arm Description

    Patients undergoing treatment with oral celecoxib

    Outcomes

    Primary Outcome Measures

    Time to first recurrence
    Safety assessed by description of grade 1-4 adverse events

    Secondary Outcome Measures

    Full Information

    First Posted
    January 16, 2015
    Last Updated
    January 21, 2015
    Sponsor
    Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02343614
    Brief Title
    Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
    Official Title
    Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Muscle Invasive Bladder Cancer
    Keywords
    Intermediate risk, Cox-2 inhibitors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    N/A
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ARM A
    Arm Type
    Experimental
    Arm Description
    Patients undergoing treatment with oral celecoxib
    Intervention Type
    Drug
    Intervention Name(s)
    Celecoxib
    Primary Outcome Measure Information:
    Title
    Time to first recurrence
    Time Frame
    5 years
    Title
    Safety assessed by description of grade 1-4 adverse events
    Time Frame
    5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincenzo VP Pagliarulo, Medical Doctor
    Organizational Affiliation
    Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

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