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

Jonsson Comprehensive Cancer Center

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: celecoxib

Study type

Interventional

Funder types

Other

Identifiers

NCT00020878

NCI-G01-1966

UCLA-0012067

CDR0000068727

Details and patient eligibility

About

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.

Full 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.

Enrollment

21 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

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