Celecoxib |
Celebrex |
Clinical Trial: Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
This study is no longer recruiting patients.
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
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 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:
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
Jenny T. Mao, MD, Study Chair, Jonsson Comprehensive Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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
Resources
- Celebrex (Drug Digest)
- Celebrex Consumer Information (U.S. Food and Drug Administration)

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