Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Non Muscle Invasive Bladder Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Time to first recurrence

Time frame: 5 years

Safety assessed by description of grade 1-4 adverse events

Time frame: 5 years