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Completed

NCT Number: NCT00020878

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

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

Other names: Celebrex

Primary outcomes

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

    Time frame: 1 year

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

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

Celecoxib for Chemoprevention of Primary Lung Cancer

Important dates

Study start
2001
Primary completion
2002
Study completion
2009
First posted
Jan 27, 2003
Registry last updated
Aug 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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