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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020878
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 3, 2020
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: celecoxib Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Celecoxib for Chemoprevention of Primary Lung Cancer
Study Start Date : March 2001
Actual Primary Completion Date : November 2002
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Study
See intervention description.
Drug: celecoxib
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Other Name: Celebrex

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00020878

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Principal Investigator: Jenny T. Mao, MD Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00020878    
Other Study ID Numbers: CDR0000068727
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: March 2016
Keywords provided by Jonsson Comprehensive Cancer Center:
non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action