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
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
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
NCT ID
NCT02343614
First Posted
January 16, 2015
Last Updated
January 21, 2015
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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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