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

This study is ongoing, but not recruiting participants.

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

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Celecoxib    4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention
Official Title:   Celecoxib for Chemoprevention of Primary Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   September 2001

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

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)
  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
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Jenny T. Mao, MD     Jonsson Comprehensive Cancer Center    
  More Information


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

Study ID Numbers:   CDR0000068727, UCLA-0012067, NCI-G01-1966
First Received:   July 11, 2001
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00020878
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Celecoxib
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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