Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules

NCT02169271 | Completed Phase 2 Results DMC

• 14 other identifiers: NCI-2014-01311IEO-833/13FHHSN261201200034IEIO 833/13F2013-004862-32TO-RFP AN01-CN-2012-00034IEO 833/13F (IEO37)MDACC: 2013-0732IEO 372013-0732MDA2013-01-01N01CN00034P30CA016672
• Study Type: interventional
• Target: 109
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Current Smoker; Former Smoker; Multiple Pulmonary Nodules; Tobacco Use Disorder

Outcome Measures

Primary Outcomes (1)

• Change in the Sum of Longest Diameters of Baseline Target Nodules (Person-specific Analysis)

  Difference (12 month-baseline) in the sum of longest diameters of baseline target nodules.

  Twelve-month treatment

Secondary Outcomes (8)

• Change in the Sum of Baseline Target Nodules Diameters (Per Nodules Analysis)

  Baseline up to 1 year

• Change in Lesion Volume

  Baseline to 1 year

• Change in Lesion Density

  Baseline up to 1 year

• Modulation of Thromboxane B2

  Baseline up to 1 year

• Modulation of Prostaglandin E Metabolites (Normalized to Urinary Creatinine Concentration)

  Baseline up to 1 year

Study Arms (2)

Arm I (acetylsalicylic acid)

EXPERIMENTAL

Patients receive acetylsalicylic acid PO QD for 12 months.

Drug: Aspirin; Other: Laboratory Biomarker Analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 12 months.

Other: Laboratory Biomarker Analysis; Other: Placebo

Interventions

Aspirin DRUG

Given PO

Also known as: Acetylsalicylic Acid, ASA, Aspergum, Ecotrin, Empirin, Entericin, Extren, Measurin

Arm I (acetylsalicylic acid)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (acetylsalicylic acid); Arm II (placebo)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Smoking Cessation; Multiple Pulmonary Nodules; Tobacco Use Disorder

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Therese Bevers / Clinical Cancer Prevention Department
• Organization: UT MD Anderson Cancer Center

tbevers@mdanderson.org

713-745-8048

Study Officials

• Bernardo Bonanni

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: November 21, 2014
• Primary Completion: July 13, 2018
• Study Completion: February 14, 2020
• Last Updated: May 21, 2020
• Results First Posted: May 21, 2020

Record last verified: 2020-05

Locations

US (1); IT (1)