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

Information source: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

Intervention: celecoxib (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Jonsson Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Jenny T. Mao, MD, Principal Investigator, Affiliation: Jonsson Comprehensive Cancer Center

Summary

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.

Clinical Details

Official title: Celecoxib for Chemoprevention of Primary Lung Cancer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

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

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

Secondary outcome:

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

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

Detailed description: 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.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 and Contacts

Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California 90095-1781, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2001
Last updated: July 27, 2012

Page last updated: August 23, 2015

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