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Celecoxib in Preventing Lung Cancer in Former Heavy Smokers | Clinical Trials | Clareo Health

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Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers

NCT00055978•University of California, Los Angeles

Summary

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers. PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.

Detailed Description

OBJECTIVES: * Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer. * Determine the safety and side effects of this drug in these patients. * Determine the quality of life of patients treated with this drug. * Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients. * Determine the effects of COX-2 inhibition on angiogenesis in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral placebo twice daily for 6 months. * Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 6 months during treatment and then annually for up to 4 years. Patients are followed annually for up to 4 years. PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study.

Eligibility

Age

45 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Heavy former smokers without prior history of NSCLC
•* Age \> 45
•* Smoked for minimum of 30 pack years
•Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:
•* Age \> 18
•* Smoked \> 10 pack years
•* Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative
•* At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer
•Normal blood chemistry and cell counts
•Negative pregnancy test

Exclusion Criteria

•Framingham 10-year-risk for coronary artery disease score \> 10%
•History of cardiovascular disease
•Evidence of diffuse coronary calcification on screening CT
•Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted
•Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs
•Liver dysfunction \[abnormally elevated liver function tests \[transaminases (ALT, AST) \> ULN, alkaline phosphatase (ALKP) \> 1.5 ULN\]\] or history of cirrhosis
•No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed \< 2 years, there must be no active symptoms, and endoscopic confirmation of healing
•Renal dysfunction \[abnormally elevated blood urea nitrogen (BUN) \> 1.5 ULN and creatinine \> ULN\]
•End state respiratory disease
•Unstable angina or a history of significant coronary artery disease
+11 more criteria

Locations (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Key Dates

Start Date

October 1, 2002

Primary Completion Date

March 1, 2008

Completion Date

May 1, 2009

Last Updated

June 20, 2011

Enrollment

112

ACTUAL participants

Conditions

Lung Cancer

Interventions

celecoxib

DRUG

placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

Inclusion Criteria

Exclusion Criteria

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