<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/NCT02200354</url>
  </required_header>
  <id_info>
    <org_study_id>PEM-RE-2014</org_study_id>
    <nct_id>NCT02200354</nct_id>
  </id_info>
  <brief_title>The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab</brief_title>
  <official_title>The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kobe City General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kobe City General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and&#xD;
      cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the&#xD;
      PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not&#xD;
      progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted&#xD;
      from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab&#xD;
      continuous maintenance might be better treatment option, considering the results from&#xD;
      AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients.&#xD;
      Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with&#xD;
      bevacizumab,we conducted this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    inclusion speed&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>progression free survival</measure>
    <time_frame>Within the study period and until tumor proression, an expected average of 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>response rate</measure>
    <time_frame>The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to treatment failure (TTF)</measure>
    <time_frame>From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Advanced Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>pemetrexed with bevacizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pemetrexed with bevacizumab</intervention_name>
    <arm_group_label>pemetrexed with bevacizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 Years and older&#xD;
&#xD;
          -  PS0-2&#xD;
&#xD;
          -  Advanced non-squamous non-small cell lung cancer; AND&#xD;
&#xD;
          -  Patients who have received more than 4 cycles of pemetrexed therapy before the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Interstitial pneumonia; AND&#xD;
&#xD;
          -  Abnormal blood test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daichi Fujimoto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kobe City Medical Center General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>650-0046</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kobe City General Hospital</investigator_affiliation>
    <investigator_full_name>Daichi Fujimoto</investigator_full_name>
    <investigator_title>doctor, division of respiratory medicine</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Pemetrexed</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/NCT02200354
org study id: PEM-RE-2014
nct id: NCT02200354
lead sponsor: 
has dmc: No
For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and
      cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the
      PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not
      progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted
      from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab
      continuous maintenance might be better treatment option, considering the results from
      AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients.
      Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with
      bevacizumab,we conducted this study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free survival
time frame: Within the study period and until tumor proression, an expected average of 16 weeks
measure: response rate
time frame: The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks
measure: overall survival
time frame: From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years
measure: time to treatment failure (TTF)
time frame: From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
measure: Number of Participants with Adverse Events
time frame: From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years
arm group label: pemetrexed with bevacizumab
arm group type: Experimental
description: pemetrexed rechallenge with bevacizumab pemetrexed (500mg/m2 day1) bevacizumab (15mg/kg day1)
intervention type: Drug
intervention name: pemetrexed with bevacizumab
arm group label: pemetrexed with bevacizumab
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Daichi Fujimoto, MD
role: Principal Investigator
affiliation: Kobe City Medical Center General Hospital
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Kobe City General Hospital
investigator full name: Daichi Fujimoto
investigator title: doctor, division of respiratory medicine
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Bevacizumab
mesh term: Pemetrexed