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Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
This study is ongoing, but not recruiting participants.
Study NCT00020878   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: July 23, 2008   History of Changes

July 11, 2001
July 23, 2008
September 2001
 
 
 
Complete list of historical versions of study NCT00020878 on ClinicalTrials.gov Archive Site
 
 
 
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
Celecoxib for Chemoprevention of Primary Lung Cancer

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.

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.

Phase II
Interventional
Prevention
Lung Cancer
Drug: celecoxib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Smoked more than 20 pack years
  • Evidence of airflow obstruction (FEV_1 less than 80%)
  • No end-stage respiratory disease (e.g., FEV_1 less than 0.8 liters, or resting or exertional hypoxemia)

PATIENT CHARACTERISTICS:

Age:

  • Over 45

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No history of liver dysfunction

Renal:

  • No renal dysfunction

Cardiovascular:

  • No hypertension
  • No cardiac condition aggravated by fluid retention and edema
  • No unstable angina

Pulmonary:

  • See Disease Characteristics

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 7 days after study participation
  • No malignancy
  • No hypersensitivity to celecoxib
  • No allergic reaction to sulfonamides
  • No prior allergic reaction (urticaria or asthma) to aspirin or other NSAIDs
  • No prior gastrointestinal ulceration, bleeding, or perforation
  • No concurrent medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No concurrent non-steroidal anti-inflammatory drugs (NSAIDs)
  • No concurrent medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes (e.g., rifampin, fluconazole, fluvastatin, zafirlukast, sulfaphenazole, cimetidine, fluoxetine, paroxetine, quinidine, amiodarone, or ritonavir)
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020878
 
CDR0000068727, UCLA-0012067, NCI-G01-1966
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Jenny T. Mao, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP