Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.

Detailed Description
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OBJECTIVES: Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers. Determine the safety and long-term side effects of this drug in this population. OUTLINE: Patients receive oral celecoxib twice daily for 6 months. Patients are followed at 2 weeks and then at 6 months. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.

Official Title
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Celecoxib for Chemoprevention of Primary Lung Cancer

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: celecoxib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 45 Smoked > 20 pack years Exclusion Criteria: Concurrent use of NSAIDs Hypersensitivity to celecoxib Documented allergic-type reaction to sulfonamides History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs History of liver dysfunction Hypertension or cardiac conditions aggravated by fluid retention and edema Previous history of gastrointestinal ulceration, bleeding, or perforation Renal dysfunction End stage respiratory disease Unstable angina Other malignancy Pregnancy Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>See intervention description. | Drug: celecoxib<br>* Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.<br>* Other names: Celebrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. |  | 1 year | 
| Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC |  | 2 years | 
| Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-small cell lung cancer