<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/NCT01693276</url>
  </required_header>
  <id_info>
    <org_study_id>UCC-GI-01</org_study_id>
    <nct_id>NCT01693276</nct_id>
  </id_info>
  <brief_title>Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer</brief_title>
  <official_title>Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Olugbenga Olowokure</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will analyze the effects, good and/or bad, of the drug Abraxane in combination&#xD;
      with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally&#xD;
      advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in&#xD;
      this study are FDA-approved for use in patients with pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long term goal is to improve survival of patients with unresectable pancreatic cancer.&#xD;
      Additional potential benefits include increased probability of local control and decreased&#xD;
      distant metastases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow accrual&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>Phase 1/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>Increase overall survival</measure>
    <time_frame>23 months</time_frame>
    <description>Estimated increase in median survival from 11 to 16 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of local control</measure>
    <time_frame>baseline to average up to 24 weeks</time_frame>
    <description>Determine rate of local control from the date of start of treatment to the date of the time of local progression</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>Gemzar/Abraxane and Radiation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT.&#xD;
Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks.</description>
    <arm_group_label>Gemzar/Abraxane and Radiation Therapy</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abraxane</intervention_name>
    <description>Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT</description>
    <arm_group_label>Gemzar/Abraxane and Radiation Therapy</arm_group_label>
    <other_name>nab-Paclitaxel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>IMRT Dose escalation: 60 Gy (2 Gy/fraction)</description>
    <arm_group_label>Gemzar/Abraxane and Radiation Therapy</arm_group_label>
    <other_name>RT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically proven carcinoma of the pancreas that is locally&#xD;
             advanced&#xD;
&#xD;
          -  ECOG performance status 0- 2&#xD;
&#xD;
          -  Adequate labs&#xD;
&#xD;
          -  No prior abdominal radiation therapy&#xD;
&#xD;
          -  No other concurrent clinically evident malignancy, except inactive nonmelanoma skin&#xD;
             cancer, inactive cervical cancer, or other cancer for which the patient has been&#xD;
             disease-free for 5 years&#xD;
&#xD;
          -  All disease must be encompassed within a radiotherapy portal&#xD;
&#xD;
          -  Not pregnant or nursing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has metastatic disease on radiological staging&#xD;
&#xD;
          -  systemic therapy.&#xD;
&#xD;
          -  Patient has known active infection with HIV, hepatitis C or hepatitis B&#xD;
&#xD;
          -  Patient has serious medical risk factors involving any of the major organ systems such&#xD;
             that the Investigator considers it unsafe for the patient to receive an experimental&#xD;
             research drug.&#xD;
&#xD;
          -  Patient is deemed to be have obvious resectable disease at presentation&#xD;
&#xD;
          -  Received any investigational agent within a month prior to enrollment.&#xD;
&#xD;
          -  Neuroendocrine tumors of the pancreas&#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>Olugbenga Olowokure, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle Mierzwa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>October 23, 2015</last_update_submitted>
  <last_update_submitted_qc>October 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Olugbenga Olowokure</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>pancreatic cancer</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>Gemcitabine</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</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/NCT01693276
org study id: UCC-GI-01
nct id: NCT01693276
lead sponsor: 
has dmc: No
This study will analyze the effects, good and/or bad, of the drug Abraxane in combination
      with gemcitabine and gemcitabine with concurrent radiation therapy for patients with locally
      advanced pancreatic cancer that cannot be removed by surgery. All of the medications used in
      this study are FDA-approved for use in patients with pancreatic cancer.
The long term goal is to improve survival of patients with unresectable pancreatic cancer.
      Additional potential benefits include increased probability of local control and decreased
      distant metastases.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Increase overall survival
time frame: 23 months
description: Estimated increase in median survival from 11 to 16 months
measure: Rate of local control
time frame: baseline to average up to 24 weeks
description: Determine rate of local control from the date of start of treatment to the date of the time of local progression
arm group label: Gemzar/Abraxane and Radiation Therapy
arm group type: Experimental
description: Patients will receive 2 cycles of gemcitabine and abraxane prior to the start of chemoradiation. Chemoradiation will commence 2 week after the completion of second cycle of gemcitabine/abraxane. Patients will receive an additional 2 cycles of gemcitabine and abraxane to start 2-4 weeks after the completion of chemoradiation. After the last two cycles of chemotherapy, if well tolerated with continued tumor response additional cycles of chemotherapy may be given.
intervention type: Drug
intervention name: Gemcitabine
description: gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT.
Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks.
arm group label: Gemzar/Abraxane and Radiation Therapy
other name: Gemzar
intervention type: Drug
intervention name: Abraxane
description: Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT
arm group label: Gemzar/Abraxane and Radiation Therapy
other name: nab-Paclitaxel
intervention type: Radiation
intervention name: Radiation Therapy
description: IMRT Dose escalation: 60 Gy (2 Gy/fraction)
arm group label: Gemzar/Abraxane and Radiation Therapy
other name: RT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olugbenga Olowokure, MD
role: Principal Investigator
affiliation: University of Cincinnati
last name: Michelle Mierzwa, MD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cincinnati
investigator full name: Olugbenga Olowokure
investigator title: Assistant Professor
mesh term: Pancreatic Neoplasms
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Albumin-Bound Paclitaxel