Celecoxib for the Treatment of Non-muscle Invasive Bladder Cancer

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.

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Key information

Conditions

Non Muscle Invasive Bladder Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

Primary outcomes

Time to first recurrence

Time frame: 5 years
Safety assessed by description of grade 1-4 adverse events

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Important dates

Study start: 2003
Primary completion: 2013
Study completion: 2014
First posted: Jan 22, 2015
Registry last updated: Jan 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed