Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00055978
First received: March 6, 2003
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Lung Cancer
Drug: celecoxib
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Modulation of the ki-67 labeling index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Phenotypic modulation of the bronchial histology [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of molecular/genetic aberrations [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Changes indicative of response to treatment in the targeted signaling pathway [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: October 2002
Study Completion Date: May 2009
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055978

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jenny T. Mao, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jenny T. Mao, Jonsson Comprehensive Cancer Center at UCLA
ClinicalTrials.gov Identifier: NCT00055978     History of Changes
Other Study ID Numbers: CDR0000271912, U01CA096134, P30CA016042, UCLA-0108074
Study First Received: March 6, 2003
Last Updated: June 16, 2011
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
non-small cell lung cancer
stage I non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014