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Status:

COMPLETED

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

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Precancerous Condition

Stage I Non-small Cell Lung Cancer

Eligibility:

All Genders

40-79 years

Phase:

PHASE2

Brief 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 t...

Detailed Description

PRIMARY OBJECTIVES: I. Compare the change in histologic grade of bronchial dysplasia, as determined from mucosal biopsy samples obtained during pre- and post-intervention autofluorescence bronchoscop...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2010

    Estimated Enrollment :

    61 Patients enrolled

    Trial Details

    Trial ID

    NCT00368927

    Start Date

    August 1 2006

    End Date

    December 1 2010

    Last Update

    May 23 2014

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Mayo Clinic in Arizona

    Scottsdale, Arizona, United States, 85259

    2

    H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, United States, 33612

    3

    Lahey Hospital and Medical Center

    Burlington, Massachusetts, United States, 01805

    4

    Mayo Clinic

    Rochester, Minnesota, United States, 55905