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Precancerous ConditionPhase 2NCT00368927

Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia

A Phase 2 study testing sulindac in people with Precancerous Condition and Stage I Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 6 sites in 2 countries.

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

This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Read more about this study

Who is it for?
Ages 40 to 79 years
What is being tested?
sulindac
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
61 participants
Where
6 sitesin 2 countries
Study dates
Aug 2006to Dec 2010
Phase
Phase 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 40 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Current or former smoker who has smoked at least 30 pack years AND meets 1 of the following criteria:
  • No prior lung cancer
  • Prior stage I non-small cell lung cancer(NSCLC) that was completely resected ≥ 1 year ago OR for which patient completed adjuvant chemotherapy ≥ 1 year ago
  • Tissue blocks, blood, and sputum samples available for research purposes
  • No carcinoma in situ
  • ECOG performance status 0-1
Show all 60Show fewer
  • Hemoglobin ≥ 12.0 g/dL (women) or hemoglobin ≥ 13.5 g/dL (men)
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥30 mL/min
  • Room air oxygen saturation ≥ 90%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Negative chest x-ray
  • Negative electrocardiogram
  • No other cancer within the past 3 years except nonmelanoma skin cancer, localized prostate, carcinoma in situ of the cervix cancer, or superficial bladder cancer
  • Treatment must have been completed > 6 months ago
  • No prior gastrointestinal ulceration, bleeding, or perforation
  • No uncontrolled illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Myocardial infarction within the past 6 months
  • Chronic renal disease
  • Chronic liver disease
  • Difficult to control hypertension
  • Psychiatric illness or social situations that would limit study compliance
  • No known HIV positivity
  • No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
  • No known sensitivity to yellow dye FD\&C Yellow #5
  • No continuous or intermittent supplemental oxygen
  • At least 6 months since prior participation in another chemoprevention trial
  • At least 6 months since prior regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids (may be eligible after washout period of 12 weeks for NSAIDs and 6 weeks for corticosteroids)
  • No prior pneumonectomy
  • No prior solid organ transplantation
  • No other concurrent investigational agents
  • No concurrent regular use of acetylsalicylic acid (aspirin) unless prescribed by a physician for prevention
  • Maximum of 1 aspirin (81 mg) per day allowed
  • No concurrent use of any of the following:
  • Methotrexate
  • Corticosteroids
  • Antiplatelet agents:
  • Warfarin
  • Ticlopidine
  • Clopidogrel bisulfate
  • Aspirin
  • Abciximab
  • Dipyridamole
  • Eptifibatide
  • Tirofiban hydrochloride
  • Lithium carbonate
  • Cyclosporine
  • Hydralazine
  • Angiotensin-converting enzyme (ACE) inhibitors (ACE receptor antagonists are allowed)
  • Angiotensin receptor blockers

Who cannot join

None listed.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States5 sites

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

Canada1 site

  • British Columbia

    Vancouver, British Columbia, V5Z 1L3

Other trials in Canada

About this study

Official title: Randomized, Phase IIb Trial of Sulindac in Smokers With Bronchial Dysplasia

This randomized phase II trial is studying sulindac to see how well it works compared to a placebo in preventing lung cancer in current or former smokers with bronchial dysplasia. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sulindac may prevent lung cancer from forming in patients with bronchial dysplasia. It is not yet known whether sulindac is more effective than a placebo in preventing lung cancer in patients with bronchial dysplasia.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Compare the change in histologic grade of bronchial dysplasia, as determined from mucosal biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscopy exams, in current or former smokers with bronchial dysplasia treated with sulindac vs placebo.

SECONDARY OBJECTIVES:

  1. Compare the change in number of dysplastic lesions, as determined from mucosal biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscopy exams, in patients treated with these regimens.

II. Compare changes in tissue-based biomarkers (cyclooxygenase [COX]-2, 15-lipoxygenase [LOX]-1, PPAR γ, Ki-67, caspase-3, cyclin D1, cyclin E) in patients treated with these regimens.

III. Determine the safety and adverse event profiles of these regimens in these patients.

IV. Describe the frequency and patterns of bronchial dysplasia as well as biomarker characteristics in patients treated with this regimen.

  1. Establish a biospecimen repository archive for future correlative studies.

OUTLINE: This is a multicenter, double-blind, randomized, placebo-controlled study. Patients are stratified according to smoking status (current vs former), prior lung cancer (yes vs no), and number of baseline dysplastic lesions (1-3 vs > 3). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral sulindac twice daily for 6 months.

ARM II: Patients receive oral placebo twice daily for 6 months. Bronchoscopic examination and mucosal biopsy are performed at baseline and at completion of study treatment. Tissue samples are examined by immunohistochemistry for biological markers, including Ki-67, caspase-3, cyclooxygenase-2, cyclin D1, cyclin E, vascular endothelial growth factor, PPAR γ, and 15-lipoxygenase-1. Blood samples are collected for serum cotinine.

After completion of study treatment, patients are followed for up to 30 days.

Being tested
sulindac, placebo
Medical subject headings
Precancerous Conditions, Carcinoma, Non-Small-Cell Lung, Tobacco Use Disorder

What participants receive

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

  • sulindacDrug

    Also called Aflodac, Algocetil, Clinoril, SULIN

    Given orally

  • placeboOther

    Also called PLCB

    Given orally

Study groups in NCT00368927
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral sulindac twice daily for 6 months.
Receives: Drug: sulindac
Arm IIPlacebo comparatorPatients receive oral placebo twice daily for 6 months.
Receives: Other: placebo

What is being measured

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

  1. Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment

    Definition of response: complete response = regression of all dysplastic lesions (DL) to normal, hyperplasia or metaplasia with no new DL identified; partial response = regression of one or more, but not all of the DL with no new DL identified and no lesions worsening; progression = worsening at one or more sites by at least 2 histologic grades or appearance of any new DL that were not previously biopsied; stable disease = participants not classified as having a complete response, partial response, or progressive disease

    Measured: Baseline and 6 months

Secondary outcomes (1)

  1. Percent Change in Number of Dysplastic Lesions (DL) as Measured by Mucosal Biopsy Samples Before and After the Intervention

    The number of dysplastic lesions was recorded pre-intervention and post-intervention for each participant in each group. Change in the number of lesions was compared between the two intervention groups.

    Measured: Baseline and 6 months

Timeline

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

  1. First posted29 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionMay 2010
  4. Study completionDec 2010

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368927
Sponsor's protocol ID
NCI-2009-00836
Other IDs
NCI-2009-00836, CDR0000496457, MAY03-1-02, MAYO-03-1-02, MAY03-1-02, P30CA015083, N01CN35000
Status last verified
Oct 2011
First submitted
24 Aug 2006
Last updated
23 May 2014

Publications

  • Limburg PJ, Mandrekar SJ, Aubry MC, Ziegler KL, Zhang J, Yi JE, Henry M, Tazelaar HD, Lam S, McWilliams A, Midthun DE, Edell ES, Rickman OB, Mazzone P, Tockman M, Beamis JF, Lamb C, Simoff M, Loprinzi C, Szabo E, Jett J; Cancer Prevention Network. Randomized phase II trial of sulindac for lung cancer chemoprevention. Lung Cancer. 2013 Mar;79(3):254-61. doi: 10.1016/j.lungcan.2012.11.011. Epub 2012 Dec 20.

    PubMed 23261228

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sulindac in people with Precancerous Condition and Stage I Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 6 sites in 2 countries.

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 60 inclusion and 0 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 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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 8 Jan 2014). 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?

Percentage of Participants With Response Determined by Change in Histologic Grade of Bronchial Dysplasia as Measured by Mucosal Biopsy Samples Before and After Treatment (time frame: Baseline and 6 months). 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 NCT00368927, which also lists 1 linked publication.

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 23 May 2014.

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