Brief Title
Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
Official Title
Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin
Brief Summary
This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes in biomarkers that occur during treatment with acetylsalicylic acid
Detailed Description
PRIMARY OBJECTIVES: 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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day
Secondary Outcome
Change in PGE-M levels from baseline and daily for 7 days after discontinuation of a 7-day course of 325 mg ASA per day
Condition
Adenocarcinoma of the Lung
Intervention
acetylsalicylic acid
Study Arms / Comparison Groups
Prevention (acetylsalicylic acid)
Description: Patients receive acetylsalicylic acid PO for 7 days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
4
Start Date
October 2012
Completion Date
August 2018
Primary Completion Date
June 2018
Eligibility Criteria
Inclusion Criteria: - Have confirmed (stage IIIb-IV) or recurrent non-small cell lung cancer, adenocarcinoma histology - 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: - Know allergy to aspirin or other nonsteroidal anti-inflammatory drugs - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Leora Horn, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01707823
Organization ID
VICC THN 1227
Secondary IDs
NCI-2012-01800
Responsible Party
Principal Investigator
Study Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Leora Horn, Principal Investigator, Vanderbilt-Ingram Cancer Center
Verification Date
January 2020