Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer
- Registration Number
- NCT02343614
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARM A Celecoxib Patients undergoing treatment with oral celecoxib
- Primary Outcome Measures
Name Time Method Time to first recurrence 5 years Safety assessed by description of grade 1-4 adverse events 5 years
- Secondary Outcome Measures
Name Time Method