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

NCT ID: NCT00020878

Last Updated: 2020-08-03

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Study

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Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Celebrex

Eligibility Criteria

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Inclusion Criteria

* Age \> 45
* Smoked \> 20 pack years

Exclusion Criteria

* Concurrent use of NSAIDs
* 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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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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