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Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
placebo
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer, stage I non-small cell lung cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive oral placebo twice daily for 6 months.

Patients receive oral celecoxib twice daily for 6 months.

Outcomes

Primary Outcome Measures

Modulation of the ki-67 labeling index
Phenotypic modulation of the bronchial histology

Secondary Outcome Measures

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

Full Information

First Posted
March 6, 2003
Last Updated
June 16, 2011
Sponsor
University of California, Los Angeles
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00055978
Brief Title
Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
Official Title
Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, Los Angeles
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
non-small cell lung cancer, stage I non-small cell lung cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral placebo twice daily for 6 months.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive oral celecoxib twice daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex, Celebra
Intervention Description
Given orally. 400mg twice daily for 6 months.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Modulation of the ki-67 labeling index
Time Frame
5 years
Title
Phenotypic modulation of the bronchial histology
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Evidence of molecular/genetic aberrations
Time Frame
5 years
Title
Changes indicative of response to treatment in the targeted signaling pathway
Time Frame
5 years
Title
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny T. Mao, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

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