Trial intelligence / Profile preview

Celecoxib for Lung Cancer Chemoprevention in Ex-Smokers

NCT00055978Phase 2

Key facts

Status: Completed
Start: Oct 2002
Primary completion: Mar 2008
Countries: 1
Sponsor: University of California, Los Angeles
Modality: Small Molecules

Drugs: celecoxib oral solution
Conditions: lung cancer

Overview

Phase 2, randomised, double-blind trial of celecoxib oral solution in lung cancer (2 arms), sponsored by University of California, Los Angeles. Primary endpoints: Modulation of the ki-67 labeling index at 5 years and Phenotypic modulation of the bronchial histology at 5 years. Started Oct 2002; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Placebo
Oral placebo twice daily
Celecoxib
Oral celecoxib 400mg twice daily

Who it enrols

Former heavy smokers (>30 pack years, age >45) or former smokers with prior cured Stage I NSCLC (>10 pack years, age >18). Excludes patients with high cardiovascular risk, NSAID use, or liver/renal dysfunction.

Endpoints

Primary

Modulation of the ki-67 labeling index5 years
Phenotypic modulation of the bronchial histology5 years

Secondary

Evidence of molecular/genetic aberrations5 years
Changes indicative of response to treatment in the targeted signaling pathway5 years
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis5 years

Beyond the preview

Go deeper on NCT00055978.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00055978.