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Celecoxib for Chemoprevention of Primary Lung Cancer


Phase 2
45 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Celecoxib for Chemoprevention of Primary Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 years

Safety Issue:

No

Principal Investigator

Jenny T. Mao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000068727

NCT ID:

NCT00020878

Start Date:

March 2001

Completion Date:

May 2009

Related Keywords:

  • Lung Cancer
  • non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

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