Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
Condition: Current Smoker; Former Smoker; Multiple Pulmonary Nodules; Tobacco Use Disorder
MeSH terms: Multiple Pulmonary Nodules; Tobacco Use Disorder
Intervention: Aspirin; Laboratory Biomarker Analysis; Placebo
Intervention description: Given PO; Correlative studies; Given PO
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies acetylsalicylic acid compared to placebo in treating
      high-risk patients with subsolid lung nodules. A nodule is a growth or lump that may be
      malignant (cancer) or benign (not cancer). Chemoprevention is the use of drugs to keep cancer
      from forming or coming back. The use of acetylsalicylic acid may keep cancer from forming in
      patients with subsolid lung nodules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asymptomatic current or former smokers (having stopped within the last 20 years)

          -  Smoking history >= 20 pack/years; subjects must be included in an ongoing annual
             screening with low dose CT scan or must have two consecutive CT outside the context of
             a screening program confirming subsolid nodules

          -  Subjects must have subsolid (non solid or partially solid) nodules with size between 4
             and 10 mm with any volume doubling time (VDT) not candidate to surgical excision
             and/or subsolid (non solid or partially solid) nodule larger than 10 mm with VDT
             higher than 400 days and not candidate to surgical excision

          -  All nodules should be persistent at least after three months follow up with 1
             dimension (1d)-CT; a reduction up to 15% of the diameter of the largest target nodule
             from the previous CT scan is allowed

          -  All current smokers should accept to receive support for smoking cessation

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

          -  Leukocytes >= 3,000/microliter

          -  Absolute neutrophil count >= 1,500/microliter

          -  Platelets >= 100,000/microliter

          -  Total bilirubin =< 2 x institutional upper limit of normal (ULN) and/or history of
             Gilbert's syndrome

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 1.5 x institutional ULN

          -  Serum creatinine =< institutional ULN

          -  Women of child-bearing potential (from first menstruation to 1 year after last
             menstruation) must agree to use adequate contraception (hormonal or barrier method of
             birth control; abstinence) prior to study entry and 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

          -  Ability to understand and the willingness to sign a written informed consent document

          -  Signed informed consent

        Exclusion Criteria:

          -  Subjects with chronic treatment (at least twice/week for more than 3 months) with
             aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)

          -  History of allergic reactions attributed to compounds of similar chemical or
             biological composition to aspirin, NSAIDs, cyclooxygenase-2 (COX2) inhibitors

          -  Invasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell
             carcinoma) diagnosed during the last 2 years before randomization; stage I-II invasive
             malignancies that were diagnosed more than 2 years prior to randomization and have
             been treated curatively are allowed as long as all treatment is finished at least 18
             months prior to randomization

          -  History of therapeutic doses of anticoagulants including warfarin and low molecular
             weight heparin (e.g. for prior deep venous thrombosis and pulmonary embolisms) in the
             preceding year

          -  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 women are excluded from this study; breastfeeding should be discontinued if
             the mother is treated with aspirin

          -  Individual may not be receiving any other investigational agents, antiplatelet agents
             (e.g. aspirin, clopidogrel [Plavix or others]), anticoagulants (e.g. heparin or
             heparinoids, Coumadin, or others), methotrexate, lithium

          -  Participants with bleeding diathesis, history of gastric/duodenal ulcers in the last 5
             years, NSAID-precipitated bronchospasm, patients unwilling or unable to limit alcohol
             consumption to i.e. =< 3 alcohol drinks a day

          -  Participants who in the opinion of the principal investigator (PI) will be at higher
             risk of acetylsalicylic acid (ASA)-related complications

          -  Participants with known inability to adequately absorb oral medication