Non Muscle Invasive Bladder Cancer
Conditions
Keywords
Intermediate risk, Cox-2 inhibitors
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.
Interventions
DRUGCelecoxib
Sponsors
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first recurrence | 5 years |
| Safety assessed by description of grade 1-4 adverse events | 5 years |
Outcome results
None listed