<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01707823</url>
  </required_header>
  <id_info>
    <org_study_id>VICC THN 1227</org_study_id>
    <secondary_id>NCI-2012-01800</secondary_id>
    <secondary_id>P50CA090949</secondary_id>
    <nct_id>NCT01707823</nct_id>
  </id_info>
  <brief_title>Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer</brief_title>
  <official_title>Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt-Ingram Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Vanderbilt-Ingram Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with&#xD;
      stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients&#xD;
      with cancer in the laboratory may help doctors learn more about changes in biomarkers that&#xD;
      occur during treatment with acetylsalicylic acid&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine whether ASA (acetylsalicylic acid) 325 mg inhibits prostaglandin E2 (PGE2)&#xD;
      biosynthesis in patients with early stage non-small cell lung cancer (NSCLC). Cyclooxygenase&#xD;
      (COX) catalytic activity will be determined by measuring the metabolite of PGE2,&#xD;
      11alpha-hydroxy-9,12-dioxo-2,3,4,5-tetranor-prostane-1,20 dioic acid (PGE-M) in urine pre-&#xD;
      and post-ASA 325 mg as a surrogate of systemic PGE2 biosynthesis.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine whether COX-2 protein has a slow turnover in adenocarcinoma of the lung. COX&#xD;
      turnover will be determined by measuring urinary PGE-M levels daily for 7 days after&#xD;
      discontinuing ASA 325 mg. COX-2 and Prostaglandin expression will also be measured in tumor&#xD;
      samples of patients taken at the time of surgery.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive acetylsalicylic acid orally (PO) for 7 days and urine is collected for 7&#xD;
      days post therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding unavailable&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day</measure>
    <time_frame>14 days</time_frame>
    <description>PGE2 is a product of the COX-2 protein. Measurement of its urinary metabolite PGE-M would indicate the level of systemic biosynthesis of PGE2 and thus inhibition of COX-2 product formation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>14 days</time_frame>
    <description>PGE-M is a metabolite of PGE2 in urine. PGE2 is a product of the COX-2 protein. Evidence suggests that COX-2 and PGE2 participate in tumor growth, apoptosis and metastasis, angiogenesis and abrogation of the tumor response. ASA inhibits COX-2. A slow rate of recovery in urinary levels of urinary PGE-M would indicate the rate of catalytically active COX-2 after discontinuation of ASA and may explain the efficacy of once daily low-dose ASA.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Adenocarcinoma of the Lung</condition>
  <condition>Recurrent Non-small Cell Lung Cancer</condition>
  <condition>Stage IA Non-small Cell Lung Cancer</condition>
  <condition>Stage IB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIB Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIA Non-small Cell Lung Cancer</condition>
  <condition>Stage IIIB Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Prevention (acetylsalicylic acid)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive acetylsalicylic acid PO for 7 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>acetylsalicylic acid</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Prevention (acetylsalicylic acid)</arm_group_label>
    <other_name>ASA</other_name>
    <other_name>Ecotrin</other_name>
    <other_name>Empirin</other_name>
    <other_name>Extren</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laboratory biomarker analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Prevention (acetylsalicylic acid)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have confirmed (stage IIIb-IV) or recurrent non-small cell lung cancer, adenocarcinoma&#xD;
             histology&#xD;
&#xD;
          -  Understand and voluntarily sign an informed consent document prior to any study&#xD;
             related assessments or procedures are conducted&#xD;
&#xD;
          -  Anticipated that they will complete all study procedures&#xD;
&#xD;
          -  Ability to swallow pills&#xD;
&#xD;
          -  No aspirin in the last 7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Know allergy to aspirin or other nonsteroidal anti-inflammatory drugs&#xD;
&#xD;
          -  History of allergic reaction to aspirin or other non-steroidal anti-inflammatory&#xD;
             drugs, including ibuprofen&#xD;
&#xD;
          -  Any other concomitant serious illness or organ system dysfunction which in the opinion&#xD;
             of the investigator would either compromise patient safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leora Horn</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt-Ingram Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-6838</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.vicc.org/ct/</url>
    <description>Vanderbilt-Ingram Cancer Center, Find a Clinical Trial</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 10, 2020</last_update_submitted>
  <last_update_submitted_qc>January 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Leora Horn, MD</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01707823
org study id: VICC THN 1227
secondary id: NCI-2012-01800
secondary id: P50CA090949
nct id: NCT01707823
lead sponsor: 
collaborator: 
has dmc: Yes
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
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day
time frame: 14 days
description: PGE2 is a product of the COX-2 protein. Measurement of its urinary metabolite PGE-M would indicate the level of systemic biosynthesis of PGE2 and thus inhibition of COX-2 product formation.
measure: 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
time frame: 14 days
description: PGE-M is a metabolite of PGE2 in urine. PGE2 is a product of the COX-2 protein. Evidence suggests that COX-2 and PGE2 participate in tumor growth, apoptosis and metastasis, angiogenesis and abrogation of the tumor response. ASA inhibits COX-2. A slow rate of recovery in urinary levels of urinary PGE-M would indicate the rate of catalytically active COX-2 after discontinuation of ASA and may explain the efficacy of once daily low-dose ASA.
arm group label: Prevention (acetylsalicylic acid)
arm group type: Experimental
description: Patients receive acetylsalicylic acid PO for 7 days.
intervention type: Drug
intervention name: acetylsalicylic acid
description: Given PO
arm group label: Prevention (acetylsalicylic acid)
other name: ASA
other name: Ecotrin
other name: Empirin
other name: Extren
intervention type: Other
intervention name: laboratory biomarker analysis
description: Correlative studies
arm group label: Prevention (acetylsalicylic acid)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leora Horn
role: Principal Investigator
affiliation: Vanderbilt-Ingram Cancer Center
facility: 
country: United States
url: http://www.vicc.org/ct/
description: Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Leora Horn, MD
investigator title: Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Adenocarcinoma
mesh term: Adenocarcinoma of Lung
mesh term: Aspirin