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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center Identifier:
First received: July 11, 2001
Last updated: March 2, 2016
Last verified: March 2016

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 Intervention Phase
Lung Cancer Drug: celecoxib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Celecoxib for Chemoprevention of Primary Lung Cancer

Resource links provided by NLM:

Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: March 2001
Study Completion Date: May 2009
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00020878

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Jenny T. Mao, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00020878     History of Changes
Other Study ID Numbers: CDR0000068727
P30CA016042 ( U.S. NIH Grant/Contract )
Study First Received: July 11, 2001
Last Updated: March 2, 2016

Keywords provided by Jonsson Comprehensive Cancer Center:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on September 20, 2017