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

Lung Cancer Clinical Trial

Official title:

Celecoxib for Chemoprevention of Primary Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020878
• Other study ID #: CDR0000068727
• Secondary ID: UCLA-0012067NCI-
• Status: Completed
• Phase: Phase 2
• Start date: March 2001
• Est. completion date: May 2009

Study information

• Verified date: March 2016
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2009
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.		1 year
Primary	Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2		1 year
Secondary	Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC		2 years
Secondary	Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment		2 years