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Celecoxib in Preventing Lung Cancer in Former Heavy 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: NCT00055978
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : June 20, 2011
National Cancer Institute (NCI)
Information provided by:
University of California, Los Angeles

Brief Summary:

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.

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

Detailed Description:


  • Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer.
  • Determine the safety and side effects of this drug in these patients.
  • Determine the quality of life of patients treated with this drug.
  • Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients.
  • Determine the effects of COX-2 inhibition on angiogenesis in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral placebo twice daily for 6 months.
  • Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed every 6 months during treatment and then annually for up to 4 years.

Patients are followed annually for up to 4 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
Study Start Date : October 2002
Actual Primary Completion Date : March 2008
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Celecoxib

Arm Intervention/treatment
Experimental: Arm I
Patients receive oral placebo twice daily for 6 months.
Other: placebo
Given orally

Experimental: Arm II
Patients receive oral celecoxib twice daily for 6 months.
Drug: celecoxib
Given orally. 400mg twice daily for 6 months.
Other Names:
  • Celebrex
  • Celebra

Primary Outcome Measures :
  1. Modulation of the ki-67 labeling index [ Time Frame: 5 years ]
  2. Phenotypic modulation of the bronchial histology [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Evidence of molecular/genetic aberrations [ Time Frame: 5 years ]
  2. Changes indicative of response to treatment in the targeted signaling pathway [ Time Frame: 5 years ]
  3. Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis [ Time Frame: 5 years ]

Information from the National Library of Medicine

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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:

  • Heavy former smokers without prior history of NSCLC

    • Age > 45
    • Smoked for minimum of 30 pack years
  • Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:

    • Age > 18
    • Smoked > 10 pack years
    • Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative
    • At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer
  • Normal blood chemistry and cell counts
  • Negative pregnancy test

Exclusion Criteria:

  • Framingham 10-year-risk for coronary artery disease score > 10%
  • History of cardiovascular disease
  • Evidence of diffuse coronary calcification on screening CT
  • Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted
  • Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs
  • Liver dysfunction [abnormally elevated liver function tests [transaminases (ALT, AST) > ULN, alkaline phosphatase (ALKP) > 1.5 ULN]] or history of cirrhosis
  • No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed < 2 years, there must be no active symptoms, and endoscopic confirmation of healing
  • Renal dysfunction [abnormally elevated blood urea nitrogen (BUN) > 1.5 ULN and creatinine > ULN]
  • End state respiratory disease
  • Unstable angina or a history of significant coronary artery disease
  • Other malignancies excluding non-melanoma type skin cancer and in situ cervical cancer. Persons with stage I/II head and neck cancer must be disease free for at least 12 months
  • Pregnancy
  • Lactation
  • Unwillingness to practice contraception
  • On systemic corticoid steroid therapy
  • Coagulopathy
  • Use of Coumadin
  • Concurrent use of medication know to alter or be affected by alteration of hepatic p450 2C9 enzymes.
  • Patients with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
  • Patients who had received photosensitizing agents such as hematoporphyrin derivative or chemopreventive drugs such as retinoids within 3 months prior to the bronchoscopic procedure, radiotherapy to the chest, or cytotoxic chemotherapy agents
  • Subject found to have CIS during screening bronchoscopy will be treated with local therapy prior to randomization

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): NCT00055978

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

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Responsible Party: Jenny T. Mao, Jonsson Comprehensive Cancer Center at UCLA Identifier: NCT00055978     History of Changes
Other Study ID Numbers: CDR0000271912
U01CA096134 ( U.S. NIH Grant/Contract )
P30CA016042 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: June 2011
Keywords provided by University of California, Los Angeles:
non-small cell lung cancer
stage I 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