Clinical trial NCT02343614: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Muscle Invasive Bladder Cancer
Keywords: Intermediate risk
Cox-2 inhibitors
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time to first recurrence
timeFrame: 5 years
measure: Safety assessed by description of grade 1-4 adverse events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
name: Vincenzo VP Pagliarulo, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
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