<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/NCT02241187</url>
  </required_header>
  <id_info>
    <org_study_id>14-039</org_study_id>
    <nct_id>NCT02241187</nct_id>
  </id_info>
  <brief_title>Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection</brief_title>
  <official_title>Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cold Spring Harbor Laboratory</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weizmann Institute of Science</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <brief_summary>
    <textblock>
      This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab&#xD;
      given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In&#xD;
      Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be&#xD;
      studied. Also, the effects of PEGPH20 on tumors will be studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2014</start_date>
  <completion_date type="Actual">September 13, 2016</completion_date>
  <primary_completion_date type="Actual">September 13, 2016</primary_completion_date>
  <phase>N/A</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>Effects of PEGPH20</measure>
    <time_frame>1 year</time_frame>
    <description>administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of Administration of PEGPH20 and Cetuximab</measure>
    <time_frame>1 year</time_frame>
    <description>in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>PEGPH20 And Cetuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 participants will undergo DW- &amp; DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) &amp; (DCE)-MRI for repeatability investigation &amp; T1 mapping. Optional DW- &amp; DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- &amp; DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- &amp; DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEGPH20</intervention_name>
    <arm_group_label>PEGPH20 And Cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <arm_group_label>PEGPH20 And Cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DW &amp; DCE-MRI</intervention_name>
    <arm_group_label>PEGPH20 And Cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood draws</intervention_name>
    <description>Blood samples will be drawn at various time points.</description>
    <arm_group_label>PEGPH20 And Cetuximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically or cytologically confirmed PDAC. Pathologic&#xD;
             confirmation is mandated before initiation of any protocol specified imaging studies&#xD;
             or drug administrations. It is recognized that for some patients, histologic or&#xD;
             cytologic confirmation of cancer may be obtained following study enrollment. Patient&#xD;
             volunteers to the DW- and DCE-MRI sequence parameter optimization imaging portion of&#xD;
             the study are eligible if they have any pancreatic lesion, histologic or cytologic&#xD;
             confirmation of pathology is not required for this patient volunteer group.&#xD;
&#xD;
          -  Radiographically resectable PDAC as adjudicated by MSKCC surgical oncologist without&#xD;
             evidence of distant metastases by CT or by laparoscopy, if performed at the discretion&#xD;
             of the surgeon.&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  ECOG Performance Score of 0 - 2.&#xD;
&#xD;
          -  Absolute neutrophil count &gt; 1,500 cells/mm3&#xD;
&#xD;
          -  Platelet count &gt; 100,000 cells/mm3.&#xD;
&#xD;
          -  Adequate renal function as evidenced by serum creatinine &lt; 1.6 mg/dL.&#xD;
&#xD;
               -  INR &lt; 1.5, unless patient is on therapeutic anticoagulation where a therapeutic&#xD;
                  INR is acceptable. Anticoagulation with low molecular weight heparin or warfarin,&#xD;
                  where medically indicated, is permitted.&#xD;
&#xD;
          -  Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion of&#xD;
             the study are exempt from criteria 2, 5, 6 and 8.&#xD;
&#xD;
          -  Women of childbearing potential must have a negative pregnancy test prior to the&#xD;
             administration of protocol specified interventions.&#xD;
&#xD;
          -  Ability to understand informed consent and signing of written informed consent prior&#xD;
             to initiation of protocol therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with histology other than adenocarcinoma, e.g., neuroendocrine cancer or&#xD;
             acinar cancers, are ineligible.&#xD;
&#xD;
          -  No prior therapy for pancreas cancer is allowed.&#xD;
&#xD;
          -  Patients with metastatic or locally unresectable PDAC (resectability is as defined by&#xD;
             MSKCC pancreatic surgeon and as outlined&#xD;
&#xD;
          -  Active infection, with the exception of resolving cholangitis, will preclude&#xD;
             enrollment on the study. Preoperative interventions can only be initiated when acute&#xD;
             cholangitis has resolved.&#xD;
&#xD;
          -  Patients with known hypersensitivity to any of the components of PEGPH20 or cetuximab.&#xD;
&#xD;
          -  For patients who choose to undergo MRI imaging, hypersensitivity to MRI IV contrast&#xD;
             media not suitable for pre-medication.&#xD;
&#xD;
          -  Patients who are receiving concurrent investigational therapy or who have received&#xD;
             investigational therapy within 30 days of the first scheduled day of protocol&#xD;
             treatment (investigational therapy is defined as treatment for which there is&#xD;
             currently no regulatory authority approved indication).&#xD;
&#xD;
          -  Patients who have a history of venous or arterial thromboembolic events including&#xD;
             pulmonary embolism, deep venous thrombosis and stroke.&#xD;
&#xD;
          -  Patients who are pregnant or lactating&#xD;
&#xD;
          -  For patients who choose to undergo MRI imaging patients who are ineligible for an MRI&#xD;
             with contrast based on Radiology Department screening.&#xD;
&#xD;
          -  Any other medical condition, including mental illness or substance abuse, deemed by&#xD;
             the Investigator to be likely to interfere with a patient's ability to sign informed&#xD;
             consent, cooperate and participate in the study, or follow up procedures.&#xD;
&#xD;
          -  Patient volunteers for the DW- and DCE-MRI sequence parameter optimization portion are&#xD;
             exempt from criteria 12, 13, 14, 15, 16 and 18.&#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>Kenneth Yu, MD MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>July 21, 2017</results_first_submitted>
  <results_first_submitted_qc>September 25, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">September 27, 2017</results_first_posted>
  <last_update_submitted>September 25, 2017</last_update_submitted>
  <last_update_submitted_qc>September 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PEGPH20</keyword>
  <keyword>Cetuximab</keyword>
  <keyword>14-039</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetuximab</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Protocol Open to Accrual 09/12/2014 Protocol Closed to Accrual N/A Primary Completion Date 09/13/2016 Recruitment Location is the medical clinic</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PEGPH20 And Cetuximab</title>
          <description>5 participants will undergo DW- &amp; DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) &amp; (DCE)-MRI for repeatability investigation &amp; T1 mapping. Optional DW- &amp; DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- &amp; DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- &amp; DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.&#xD;
PEGPH20&#xD;
Cetuximab</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol closed due to lack of accrual.</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PEGPH20 And Cetuximab</title>
          <description>Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.&#xD;
However, the two participants accrued to this study were healthy participants.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" lower_limit="61" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effects of PEGPH20</title>
        <description>administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.</description>
        <time_frame>1 year</time_frame>
        <population>The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.</population>
        <group_list>
          <group group_id="O1">
            <title>PEGPH20 And Cetuximab</title>
            <description>Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.&#xD;
However, the two participants accrued to this study were healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Effects of PEGPH20</title>
          <description>administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.</description>
          <population>The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety of Administration of PEGPH20 and Cetuximab</title>
        <description>in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.</description>
        <time_frame>1 year</time_frame>
        <population>The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.</population>
        <group_list>
          <group group_id="O1">
            <title>PEGPH20 And Cetuximab</title>
            <description>Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.&#xD;
However, the two participants accrued to this study were healthy participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety of Administration of PEGPH20 and Cetuximab</title>
          <description>in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.</description>
          <population>The two participants accrued to this study were healthy participants. No participants were accrued on study for treatment. No data were collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PEGPH20 And Cetuximab</title>
          <description>Participants have radiographically resectable Pancreatic ductal adenocarcinoma (PDAC) without evidence of distant metastases by CT or laparoscopy.&#xD;
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were NOT monitored/assessed.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kenneth Yu, MD</name_or_title>
      <organization>Memorial Sloan Kettering Cancer Center</organization>
      <phone>646-888-4188</phone>
      <email>YuK1@mskcc.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02241187
org study id: 14-039
nct id: NCT02241187
lead sponsor: 
collaborator: 
collaborator: 
This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab
      given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In
      Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be
      studied. Also, the effects of PEGPH20 on tumors will be studied.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effects of PEGPH20
time frame: 1 year
description: administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation.
measure: Safety of Administration of PEGPH20 and Cetuximab
time frame: 1 year
description: in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized.
arm group label: PEGPH20 And Cetuximab
arm group type: Experimental
description: 5 participants will undergo DW- & DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) & (DCE)-MRI for repeatability investigation & T1 mapping. Optional DW- & DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- & DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- & DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.
intervention type: Drug
intervention name: PEGPH20
arm group label: PEGPH20 And Cetuximab
intervention type: Drug
intervention name: Cetuximab
arm group label: PEGPH20 And Cetuximab
intervention type: Device
intervention name: DW & DCE-MRI
arm group label: PEGPH20 And Cetuximab
intervention type: Other
intervention name: blood draws
description: Blood samples will be drawn at various time points.
arm group label: PEGPH20 And Cetuximab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth Yu, MD MSc
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Cetuximab
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 