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

Phase 2CompletedNCT00020878

Jonsson Comprehensive Cancer Center21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

celecoxibDRUG

Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, United States

Outcomes

Primary Outcomes

Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.

Time frame: 1 year

Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2

Time frame: 1 year

Secondary Outcomes

Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC

Time frame: 2 years

Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.