Sulindac in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
Condition: Precancerous Condition; Stage I Non-small Cell Lung Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Precancerous Conditions; Tobacco Use Disorder
Intervention: sulindac; placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Sulindac
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 40 Years
Maximum age: 79 Years
Healthy volunteers: No

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. 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.
    

Eligibility criteria:

        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