Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

June 16, 2011 updated by: University of California, Los Angeles

Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modulation of the ki-67 labeling index
Time Frame: 5 years
5 years
Phenotypic modulation of the bronchial histology
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of molecular/genetic aberrations
Time Frame: 5 years
5 years
Changes indicative of response to treatment in the targeted signaling pathway
Time Frame: 5 years
5 years
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

March 6, 2003

First Submitted That Met QC Criteria

March 6, 2003

First Posted (Estimate)

March 7, 2003

Study Record Updates

Last Update Posted (Estimate)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000271912
  • P30CA016042 (U.S. NIH Grant/Contract)
  • U01CA096134 (U.S. NIH Grant/Contract)
  • UCLA-0108074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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