Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers - Full Text View

Sponsor:	University of California, Los Angeles
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00020878

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: celecoxib	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Celecoxib for Chemoprevention of Primary Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

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 ]

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 [ 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 ]

Enrollment:	21
Study Start Date:	March 2001
Study Completion Date:	May 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Study See intervention description.	Drug: celecoxib Dosing will occur for a total of 6 months. 400 mg by mouth twice daily. Other Name: Celebrex

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.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020878

Locations

United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

University of California, Los Angeles

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jenny T. Mao, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jenny T. Mao, MD / Principal Investigator, UCLA
ClinicalTrials.gov Identifier:	NCT00020878 History of Changes
Other Study ID Numbers:	CDR0000068727, P30CA016042, UCLA-0012067, NCI-G01-1966
Study First Received:	July 11, 2001
Last Updated:	November 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012