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Tobacco Use DisorderPhase 1/2NCT01021215

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

A Phase 1/2 study testing Zileuton, Celecoxib and laboratory biomarker analysis in people with Tobacco Use Disorder, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tobacco Use Disorder
What is being tested?
Zileuton, Celecoxib and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
2 sitesUnited States
Study dates
May 2010to Mar 2013
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • MD Anderson Cancer Center - Consortium Lead Organzation

    Houston, Texas, 77030

  • Weill Cornell Medical College in New York City, Cornell University

    New York, New York, 10021

Other trials in United States

About this study

Official title: Modulation of Arachidonic Acid Metabolism by Chemopreventive Agents in Smokers

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Zileuton, Celecoxib, laboratory biomarker analysis
Keywords
Cancer Prevention, Smoking-related lung disease, Smoking, Celecoxib, Celebrex, Zileuton, Zyflo CR, Prevention
Medical subject headings
Tobacco Use Disorder, Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZileutonDrug

    Also called Zyflo CR

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

  • CelecoxibDrug

    Also called Celebrex

    200 mg twice daily given orally for 6 days

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01021215
Study groupRoleWhat they receive
Arm I: ZileutonExperimentalZileuton 1200 mg twice orally twice a day on days 1-6.
Receives: Drug: Zileuton; Other: laboratory biomarker analysis
Arm II: Zileuton and CelecoxibExperimentalCombined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
Receives: Drug: Zileuton; Drug: Celecoxib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Urinary PGE-M Levels (Pre and Post Treatment)

    Pre and Post treatment differences in urinary PGE-M levels measured in each treatment arm. PGE-M levels reported as median with full range (ng/mg creatinine) for Pre treatment versus Post treatment PGE-M levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).

    Measured: Baseline and Day 6

  2. Median Urinary LTE4 Levels (Pre and Post Treatment)

    Pre and Post treatment differences in urinary LTE4 levels measured in each treatment arm compared using paired t-test should the data conform to the normality assumption or one-sample Wilcoxon rank-sum test. LTE4 levels reported as median with full range (pg/mg creatinine) for Pre treatment versus Post treatment LTE4 levels among study participants compliant to treatment with evaluable urine samples at both time points (baseline and Day 6 +/- 1 day).

    Measured: Baseline and day 6

Secondary outcomes (1)

  1. Proportion of Cases With a Post-treatment Increase in Urinary PGE-M Levels

    Proportion of cases with a post-treatment increase in urinary PGE-M levels by comparing those treated with Zileuton and Celecoxib combined therapy compared to those treated with Zileuton alone. Pre/postchange in levels (Increase) derived from baseline level to Day 6 +/- 1 day. Differences in baseline levels between 2 treatment arms were examined using the Wilcoxon rank-sum test.

    Measured: Baseline to Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2009 (estimated)
  2. Study startMay 2010
  3. Primary completionAug 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01021215
Sponsor's protocol ID
NCI-2013-00730
Other IDs
NCI-2013-00730, 2009-0804, 2009-0804, N01CN35159
Status last verified
Oct 2013
First submitted
24 Nov 2009
Last updated
2 Apr 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Zileuton, Celecoxib and laboratory biomarker analysis in people with Tobacco Use Disorder, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Urinary PGE-M Levels (Pre and Post Treatment) (time frame: Baseline and Day 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01021215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.

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