Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Celecoxib as a Chemopreventive Agent in Current and Former Smokers

NCT00981201

Smoking Prevention

COMPLETED PHASE3

Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

NCT00055978

Lung Cancer

COMPLETED PHASE2

S0300, Celecoxib in Preventing Breast Cancer in Premenopausal Women

NCT00088972

Breast Cancer

TERMINATED PHASE2

Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia

NCT00101335

Head and Neck Cancer Precancerous Condition

COMPLETED PHASE2

Celecoxib in Preventing Skin Cancer

NCT00025051

Non-melanomatous Skin Cancer

WITHDRAWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

I. To determine whether short-term administration of zileuton, a 5-lipoxygenase (5-LO) inhibitor, in current smokers will suppress the formation of urinary leukotriene E4 (LTE4) and shunt arachidonic acid into the cyclooxygenase (COX) pathway, resulting in elevated urinary prostaglandin E-metabolite (PGE-M).

SECONDARY OBJECTIVES:

I. To determine whether short-term co-administration of celecoxib, a selective COX-2 inhibitor, and zileuton suppresses levels of both urinary LTE4 and PGE-M in current smokers.

II. To evaluate the association between baseline levels of urinary LTE4 and magnitude of the arachidonic acid shunt induced by zileuton.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive zileuton orally (PO) twice daily (BID) on days 1-6.

ARM II: Patients receive zileuton as in Arm I and celecoxib PO BID on days 1-6.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm I: Zileuton

Zileuton 1200 mg twice orally twice a day on days 1-6.

Group Type EXPERIMENTAL

Zileuton

Intervention Type DRUG

1200 mg twice daily given orally (PO) for 6 days

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Arm II: Zileuton and Celecoxib

Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.

Group Type EXPERIMENTAL

Zileuton

Intervention Type DRUG

1200 mg twice daily given orally (PO) for 6 days

Celecoxib

Intervention Type DRUG

200 mg twice daily given orally for 6 days

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Zileuton

1200 mg twice daily given orally (PO) for 6 days

Intervention Type DRUG

Celecoxib

200 mg twice daily given orally for 6 days

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zyflo CR Celebrex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female current tobacco smokers with more or equal to 10 pack years of self-reported smoking exposure and an average of more or equal to 10 cigarettes/day
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky 70-100%)
* Total bilirubin less or equal to 2 \* upper limit of normal (ULN)
* Direct bilirubin less or equal to 2 \* ULN
* aspartate aminotransferase (AST)/(SGOT) less or equal to 2 \* ULN
* alanine aminotransferase (ALT)/(SGPT) less or equal to 2 \* ULN
* Alkaline phosphatase less or equal to 2 \* ULN
* If the participant is female, of childbearing potential and not lactating, she has a documented negative serum pregnancy test within 14 days prior to randomization

Exclusion Criteria

* The participant has active cancer (excluding non-melanoma skin cancer)
* The participant has a history of curatively treated cancer with surgical therapy finished within 6 months prior to the Screening visit; or has had chemotherapy, cancer-related immunotherapy, hormonal therapy (other than Hormone replacement therapy (HRT) for menopause), or radiation therapy within 12 months of the screening visit
* The participant has a chronic inflammatory condition, including but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis, psoriasis, gout and pancreatitis
* The participant has an ongoing or active infection, including but not limited to HIV, pneumonia, urinary tract infection
* The participant has a history of nonsteroidal anti-inflammatory drugs (NSAIDs) use, including aspirin (low-dose aspirin also prohibited) and selective COX-2 inhibitors within the previous 4 weeks
* The participant has used zileuton or a leukotriene receptor antagonist within the previous 4 weeks
* The participant has a history of corticosteroid use (excluding topical nasal sprays and dermal application) within the last 6 weeks
* The participant has an acute or chronic kidney disorder
* The participant exhibits clinical evidence of active liver disease or history of chronic liver disease
* The participant has active cardiac disease, or a history of myocardial infarction, angina or coronary artery disease within the past 6 months
* The participant has a history of a cerebrovascular accident (CVA) or transient ischemic attack (TIA)
* The participant has a bleeding history
* The participant is taking drugs known to interact with zileuton or celecoxib, including theophylline, warfarin, propranolol, fluconazole or lithium
* The participant has received any investigational medication within 30 days of the screening visit or is scheduled to receive an investigational agent during the study
* The participant is pregnant or nursing; women must not be pregnant or lactating
* The participant is a female of child-bearing potential (women are considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile) who has not used adequate contraception (abstinence; barrier methods such as intrauterine device (IUD), diaphragm with spermicidal gel, condom, or others; and hormonal methods such as birth control pills or others) since her last menses prior to study entry
* The participant is a female of child-bearing potential or male who does not agree to use adequate contraception for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
* The participant has participated in the study previously and was withdrawn
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing participants or those who are HIV-positive will be excluded from the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No