Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer

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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