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


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Celecoxib

Celebrex 




Clinical Trial: Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

This study is no longer recruiting patients.

Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
Non-small cell lung cancer
 Drug: celecoxib
 Procedure: anti-cytokine therapy
 Procedure: antiangiogenesis therapy
 Procedure: biological response modifier therapy
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: growth factor antagonist therapy
Phase II

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Phase II Pilot Study of Celecoxib for Chemoprevention of Primary Non-Small Cell Lung Cancer in High-Risk Tobacco Smokers

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

Criteria

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)

Location Information


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

Study chairs or principal investigators

Jenny T. Mao, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068727; UCLA-0012067; NCI-G01-1966
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020878
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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December 2, 2009



Page Updated: September 6, 2005
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