Back to resultsCelecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer focused on measuring non-small cell lung cancer
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study
Arm Description
See intervention description.
Outcomes
Primary Outcome Measures
Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.
Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
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
Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment
Full Information
NCT ID
NCT00020878
First Posted
July 11, 2001
Last Updated
July 30, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00020878
Brief Title
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
Official Title
Celecoxib for Chemoprevention of Primary Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
OBJECTIVES:
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.
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Experimental
Arm Description
See intervention description.
Intervention Type
Drug
Intervention Name(s)
celecoxib
Other Intervention Name(s)
Celebrex
Intervention Description
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Primary Outcome Measure Information:
Title
Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.
Time Frame
1 year
Title
Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
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