Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
NCT ID: NCT00020878
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
21 participants
INTERVENTIONAL
2001-03-31
2009-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Study
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celecoxib
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Interventions
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celecoxib
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Smoked \> 20 pack years
Exclusion Criteria
* 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
45 Years
ALL
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jenny T. Mao, MD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Countries
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Other Identifiers
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UCLA-0012067
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1966
Identifier Type: -
Identifier Source: secondary_id
CDR0000068727
Identifier Type: -
Identifier Source: org_study_id
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