Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
NCT ID: NCT01707823
Last Updated: 2020-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
4 participants
INTERVENTIONAL
2012-10-31
2018-08-31
Brief Summary
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Detailed Description
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I. To determine whether ASA (acetylsalicylic acid) 325 mg inhibits prostaglandin E2 (PGE2) biosynthesis in patients with early stage non-small cell lung cancer (NSCLC). Cyclooxygenase (COX) catalytic activity will be determined by measuring the metabolite of PGE2, 11alpha-hydroxy-9,12-dioxo-2,3,4,5-tetranor-prostane-1,20 dioic acid (PGE-M) in urine pre- and post-ASA 325 mg as a surrogate of systemic PGE2 biosynthesis.
SECONDARY OBJECTIVES:
I. To determine whether COX-2 protein has a slow turnover in adenocarcinoma of the lung. COX turnover will be determined by measuring urinary PGE-M levels daily for 7 days after discontinuing ASA 325 mg. COX-2 and Prostaglandin expression will also be measured in tumor samples of patients taken at the time of surgery.
OUTLINE:
Patients receive acetylsalicylic acid orally (PO) for 7 days and urine is collected for 7 days post therapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
acetylsalicylic acid
Given PO
laboratory biomarker analysis
Correlative studies
Interventions
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acetylsalicylic acid
Given PO
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Understand and voluntarily sign an informed consent document prior to any study related assessments or procedures are conducted
* Anticipated that they will complete all study procedures
* Ability to swallow pills
* No aspirin in the last 7 days
Exclusion Criteria
* History of allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs, including ibuprofen
* Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Leora Horn, MD
Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Principal Investigators
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Leora Horn
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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NCI-2012-01800
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC THN 1227
Identifier Type: -
Identifier Source: org_study_id
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