Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Jonsson Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00020878

First received: July 11, 2001

Last updated: July 27, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

July 27, 2012

Start Date ^ICMJE

March 2001

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00020878 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC [ Time Frame: 6 years ] [ Designated as safety issue: No ]
Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

Official Title ^ICMJE

Celecoxib for Chemoprevention of Primary Lung Cancer

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: celecoxib

Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.

Other Name: Celebrex

Study Arm (s)

Experimental: Study

See intervention description.

Intervention: Drug: celecoxib

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00020878

Other Study ID Numbers ^ICMJE

CDR0000068727, P30CA016042, UCLA-0012067, NCI-G01-1966

Has Data Monitoring Committee

Yes

Responsible Party

Jonsson Comprehensive Cancer Center

Study Sponsor ^ICMJE

Jonsson Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Jenny T. Mao, MD

Jonsson Comprehensive Cancer Center

Information Provided By

Jonsson Comprehensive Cancer Center

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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