<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/NCT02242409</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC 2013-0138</org_study_id>
    <nct_id>NCT02242409</nct_id>
  </id_info>
  <brief_title>Study of Gemcitabine and Abraxane for Pancreas Cancer</brief_title>
  <official_title>A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label Phase II study to evaluate the clinical activity of the combination of&#xD;
      gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with&#xD;
      metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the&#xD;
      first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The&#xD;
      hypothesis is that this combination will have a 4-month progression free survival of 70% or&#xD;
      higher.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Testing of combination no longer relevant&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>4 month progression free survival</measure>
    <time_frame>2.5 years</time_frame>
    <description>The proportion of patients at 4 months from study entry with progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>2.5 years</time_frame>
    <description>Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>2.5 years</time_frame>
    <description>The time in days from study entry until progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>3 years</time_frame>
    <description>The time in days from study entry until death</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Gemcitabine/abraxane</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine and Abraxane</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine and Abraxane</intervention_name>
    <description>Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days</description>
    <arm_group_label>Gemcitabine/abraxane</arm_group_label>
    <other_name>Gemzar</other_name>
    <other_name>nanoparticle-bound paclitaxel</other_name>
    <other_name>Nab-paclitaxel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed metastatic adenocarcinoma of the pancreas&#xD;
&#xD;
          -  Progression on first line non-gemcitabine based therapy for metastatic or relapsed&#xD;
             disease&#xD;
&#xD;
          -  Radiographically measurable or evaluable disease&#xD;
&#xD;
          -  Age &gt;/= 18 years&#xD;
&#xD;
          -  ECOG performance status 0-2&#xD;
&#xD;
          -  Adequate hepatic, bone marrow and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior gemcitabine-based chemotherapy in the first line setting&#xD;
&#xD;
          -  No active severe infection, or known chronic infection with HIV or hepatitis B virus&#xD;
&#xD;
          -  No cardiovascular disease problems including unstable angina, therapy for&#xD;
             life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or&#xD;
             congestive heart failure within the last 6 months&#xD;
&#xD;
          -  No women who are pregnant or breastfeeding, and no women of childbearing potential&#xD;
             without using dual forms of contraception&#xD;
&#xD;
          -  Patients with known CNS metastases&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to gemcitabine or nab-paclitaxel&#xD;
&#xD;
          -  Anticipated patient survival under 2 months&#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>Michael Pishvaian, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown Lombardi Comprehensive Cancer Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic pancreatic cancer</keyword>
  <keyword>Second Line treatment</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>October 7, 2019</submitted>
    <returned>October 29, 2019</returned>
    <submitted>March 16, 2020</submitted>
    <returned>March 24, 2020</returned>
  </pending_results>
  <!-- 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/NCT02242409
org study id: LCCC 2013-0138
nct id: NCT02242409
lead sponsor: 
has dmc: Yes
A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting
This is an open label Phase II study to evaluate the clinical activity of the combination of
      gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with
      metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the
      first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The
      hypothesis is that this combination will have a 4-month progression free survival of 70% or
      higher.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 4 month progression free survival
time frame: 2.5 years
description: The proportion of patients at 4 months from study entry with progression or death
measure: Disease control rate
time frame: 2.5 years
description: Confirmed classification of stable disease, partial response or complete response by RECIST 1.1 criteria
measure: Progression Free Survival
time frame: 2.5 years
description: The time in days from study entry until progression or death
measure: Overall Survival
time frame: 3 years
description: The time in days from study entry until death
arm group label: Gemcitabine/abraxane
arm group type: Experimental
description: Gemcitabine and Abraxane
intervention type: Drug
intervention name: Gemcitabine and Abraxane
description: Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
arm group label: Gemcitabine/abraxane
other name: Gemzar
other name: nanoparticle-bound paclitaxel
other name: Nab-paclitaxel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Pishvaian, MD PhD
role: Principal Investigator
affiliation: Georgetown University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Gemcitabine
submitted: October 7, 2019
returned: October 29, 2019
submitted: March 16, 2020
returned: March 24, 2020