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

NCT00020878 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000068727UCLA-0012067NCI-G01-1966
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.

  1 year

• Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2

  1 year

Secondary Outcomes (2)

• Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC

  2 years

• Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment

  2 years

Study Arms (1)

Study

EXPERIMENTAL

See intervention description.

Drug: celecoxib

Interventions

celecoxib DRUG

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

Also known as: Celebrex

Study

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 45
• Smoked \> 20 pack years

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jenny T. Mao, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: November 1, 2002
• Study Completion: May 1, 2009
• Last Updated: August 3, 2020

Record last verified: 2016-03

Locations

US (1)