<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/NCT01688336</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC 1105</org_study_id>
    <nct_id>NCT01688336</nct_id>
  </id_info>
  <brief_title>FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer</brief_title>
  <official_title>Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This single arm, multi-center phase II clinical trial will assess the safety and efficacy of&#xD;
      FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and&#xD;
      borderline resectable (BR) pancreatic cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FOLFIRINOX regimen was recently presented at an international oncology meeting and represents&#xD;
      a new standard in the treatment of metastatic pancreatic cancer for selected patients. With&#xD;
      improved overall survival (OS) and response rates (RR) in the metastatic setting, we&#xD;
      hypothesize that in patients with less tumor burden, this regimen will be safe and well&#xD;
      tolerated, improve OS, progression free survival (PFS), and RR, and improve resectability&#xD;
      rates, as compared to historical data from standard single agent gemcitabine therapy for&#xD;
      unresectable locally advanced (ULA) patients and standard radiation with concurrent 5&#xD;
      fluorouracil (5FU) chemotherapy for borderline resectable (BR) patients. While both ULA and&#xD;
      BR patients will be eligible for the present study, our primary objective concerns ULA&#xD;
      patients, and we plan to enroll 45 patients in this group.&#xD;
&#xD;
      Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2&#xD;
      weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI)&#xD;
      every 2 cycles and reassessed for resectability of the tumor. All patients that are not able&#xD;
      to undergo surgical resection, due to insufficient down-staging or patient preference, will&#xD;
      continue on protocol-based therapy until disease progression, unacceptable toxicity, study&#xD;
      withdrawal, or death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Results unlikely to impact treatment patterns. Time to complete not justified.&#xD;
  </why_stopped>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">November 22, 2016</completion_date>
  <primary_completion_date type="Actual">August 22, 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>Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival for Borderline Resectable Patients</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years</time_frame>
    <description>Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions.&#xD;
Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Resectability (RR)</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>FOLFIRINOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FOLFIRINOX given to all subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FOLFIRINOX</intervention_name>
    <description>FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
    <arm_group_label>FOLFIRINOX</arm_group_label>
    <other_name>FOLFIRINOX is a chemotherapy regimen comprised of the following drugs, given in combination</other_name>
    <other_name>-Oxaliplatin</other_name>
    <other_name>-Leucovorin</other_name>
    <other_name>-Irinotecan</other_name>
    <other_name>-5FU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy confirmed adenocarcinoma of the pancreas.&#xD;
&#xD;
          -  Measurable or non-measurable but evaluable (as determined by Response Evaluation&#xD;
             Criteria in Solid Tumors version 1.1 [RECIST 1.1]) unresectable locally advanced (ULA)&#xD;
             or borderline resectable (BR) disease that is not amenable to curative intent therapy.&#xD;
             Baseline CT abdomen and chest (or MRI abdomen) within 28 days prior to initiation of&#xD;
             FOLFIRINOX is required.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.&#xD;
&#xD;
          -  No prior chemotherapy or chemoradiotherapy for pancreatic cancer.&#xD;
&#xD;
          -  Age ≥ 18 years of age.&#xD;
&#xD;
          -  Laboratory requirements at study entry:&#xD;
&#xD;
               -  Hemoglobin ≥ 10 g/dL (transfusions are acceptable)&#xD;
&#xD;
               -  absolute neutrophil count (ANC) ≥ 1.5 x 109/L&#xD;
&#xD;
               -  Platelets ≥ 100 x 109/L&#xD;
&#xD;
               -  Creatinine ≤ 1.5 x upper limit of normal (ULN), or creatinine clearance ≥ 50&#xD;
                  mL/min (estimated by Cockcroft-Gault or measured)&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x ULN&#xD;
&#xD;
               -  aspartate aminotransferase/Alanine Aminotransferase (AST/ALT) ≤ 3 x ULN&#xD;
&#xD;
               -  Gamma-Glutamyl Transferase (GGT) ≤ 5 x ULN&#xD;
&#xD;
          -  Life expectancy of at least 6 months.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy&#xD;
             test performed within 14 days prior to initiation of FOLFIRINOX.&#xD;
&#xD;
          -  WOCBP and men must agree to use adequate contraception prior to study entry, for the&#xD;
             duration of study participation, and 8 weeks after the end of treatment.&#xD;
&#xD;
          -  Before patient registration, written informed consent must be given.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Local recurrence or resectable recurrence of pancreatic cancer.&#xD;
&#xD;
          -  Other malignancies within the past 3 years except for adequately treated cervical or&#xD;
             vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors&#xD;
             (Ta, Tis &amp; T1). Any cancer curatively treated &gt;3 years prior to entry is permitted.&#xD;
&#xD;
          -  Hypersensitivity to 5FU, oxaliplatin or other platinum agent, or irinotecan or to&#xD;
             their excipients. Known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.&#xD;
&#xD;
          -  Participation in any investigational drug study within 4 weeks preceding the start of&#xD;
             study treatment. Patients are not permitted to participate in another investigational&#xD;
             drug study while being treated on this protocol.&#xD;
&#xD;
          -  Cardiac disease: Congestive heart failure symptoms &gt; class II New York Heart&#xD;
             Association (NYHA). Unstable angina (anginal symptoms at rest) or new onset angina&#xD;
             beginning within the last 3 months. Myocardial infarction within the past 6 months.&#xD;
             Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.&#xD;
&#xD;
          -  History of or suspected Gilbert's Disease (baseline testing not required).&#xD;
&#xD;
          -  Baseline peripheral neuropathy/paresthesia grade ≥ 1.&#xD;
&#xD;
          -  Active hepatitis B, unless patient has been on stable meds for at least 2 months&#xD;
             (baseline testing not required).&#xD;
&#xD;
          -  Active clinically serious infections (&gt; grade 2).&#xD;
&#xD;
          -  Any other hemorrhage/bleeding event &gt; CTCAE Grade 3 within the 12 weeks prior to the&#xD;
             first dose FOLFIRINOX.&#xD;
&#xD;
          -  Evidence or history of bleeding diathesis or coagulopathy. Note: If therapeutic&#xD;
             anticoagulation required, the investigator is encouraged to switch patient to (or&#xD;
             maintain on) low molecular weight heparin during the trial.&#xD;
&#xD;
          -  Major surgery, open biopsy or significant traumatic injury within 8 weeks of first&#xD;
             study drug. A core pancreatic or liver biopsy does not preclude the patient from the&#xD;
             study.&#xD;
&#xD;
          -  Unable or unwilling to discontinue use of ketoconazole or St John's wort. Use of&#xD;
             CYP3A4 enzyme-inducing drugs and strong CYP3A4 inhibitors is discouraged, but not&#xD;
             contraindicated.&#xD;
&#xD;
          -  Active drug or alcohol abuse.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Psychological, familial, sociological or geographical condition potentially hampering&#xD;
             compliance with the study protocol and follow-up schedule; those conditions should be&#xD;
             discussed with the patient before registration in the trial.&#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>Autumn J McRee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lineberger Comprehensive Cancer Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://unclineberger.org/</url>
    <description>UNC Lineberger Comprehensive Cancer Center homepage</description>
  </link>
  <link>
    <url>http://www.cancer.gov/</url>
    <description>National Cancer Institute (NCI) homepage</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <results_first_submitted>July 21, 2017</results_first_submitted>
  <results_first_submitted_qc>July 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 21, 2017</results_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pancreatic</keyword>
  <keyword>Phase II</keyword>
  <keyword>FOLFIRINOX</keyword>
  <keyword>Unresectable</keyword>
  <keyword>Regimen</keyword>
  <keyword>First-line</keyword>
  <keyword>Resectable</keyword>
  <keyword>Borderline</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Leucovorin</keyword>
  <keyword>Irinotecan</keyword>
  <keyword>5FU</keyword>
  <keyword>Lineberger</keyword>
  <keyword>University of North Carolina</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>Leucovorin</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
    <mesh_term>Folfirinox</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>11 patients were consented. One patient was consented but not treated due to metastatic disease and one patient was consented and not treated due to disease progression prior to protocol therapy. 9 patients went on study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>FOLFIRINOX</title>
          <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FOLFIRINOX</title>
          <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.2" lower_limit="51" upper_limit="69"/>
                  </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="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </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="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer</title>
        <description>All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).</description>
        <time_frame>Up to 3 years</time_frame>
        <population>Patients with unresectable locally advanced pancreatic cancer.</population>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer</title>
          <description>All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).</description>
          <population>Patients with unresectable locally advanced pancreatic cancer.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" lower_limit="6.2" upper_limit="NA">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival for Borderline Resectable Patients</title>
        <description>All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival for Borderline Resectable Patients</title>
          <description>All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="5.8" upper_limit="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored</description>
        <time_frame>the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="2.0" upper_limit="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate</title>
        <description>All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions.&#xD;
Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate</title>
          <description>All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions.&#xD;
Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="0" upper_limit="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR)</title>
        <description>Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR)</title>
          <description>Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), &gt;=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89" lower_limit="52" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Resectability (RR)</title>
        <description>Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.</description>
        <time_frame>Up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Resectability (RR)</title>
          <description>Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="0" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).</title>
        <description>Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).</description>
        <time_frame>Up to 3 years</time_frame>
        <population>Data were not collected</population>
        <group_list>
          <group group_id="O1">
            <title>FOLFIRINOX</title>
            <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).</title>
          <description>Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).</description>
          <population>Data were not 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>
      <time_frame>24 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FOLFIRINOX</title>
          <description>FOLFIRINOX given to all subjects&#xD;
FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:&#xD;
Oxaliplatin (85 mg/m2)&#xD;
Leucovorin (400mg/ m2)&#xD;
Irinotecan (180 mg/m2)&#xD;
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <description>Sudden death not otherwise specified (NOS)</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Calculi</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Mucositis Oral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Edema Limbs</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Vaginal Infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Alkaline Phosphatase Increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Creatinine Increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Ggt Increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Neutrophil Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>White Blood Cell Decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Peripheral Sensory Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Postnasal Drip</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash Maculo-Papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
              </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>Robin V. Johnson</name_or_title>
      <organization>UNC Lineberger Comprehensive Cancer Center</organization>
      <phone>919-966-1125</phone>
      <email>Robin_V_Johnson@med.unc.edu</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/NCT01688336
org study id: LCCC 1105
nct id: NCT01688336
lead sponsor: 
has dmc: Yes
This single arm, multi-center phase II clinical trial will assess the safety and efficacy of
      FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and
      borderline resectable (BR) pancreatic cancer.
FOLFIRINOX regimen was recently presented at an international oncology meeting and represents
      a new standard in the treatment of metastatic pancreatic cancer for selected patients. With
      improved overall survival (OS) and response rates (RR) in the metastatic setting, we
      hypothesize that in patients with less tumor burden, this regimen will be safe and well
      tolerated, improve OS, progression free survival (PFS), and RR, and improve resectability
      rates, as compared to historical data from standard single agent gemcitabine therapy for
      unresectable locally advanced (ULA) patients and standard radiation with concurrent 5
      fluorouracil (5FU) chemotherapy for borderline resectable (BR) patients. While both ULA and
      BR patients will be eligible for the present study, our primary objective concerns ULA
      patients, and we plan to enroll 45 patients in this group.

      Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2
      weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI)
      every 2 cycles and reassessed for resectability of the tumor. All patients that are not able
      to undergo surgical resection, due to insufficient down-staging or patient preference, will
      continue on protocol-based therapy until disease progression, unacceptable toxicity, study
      withdrawal, or death.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer
time frame: Up to 3 years
description: All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).
measure: Overall Survival for Borderline Resectable Patients
time frame: Up to 3 years
description: All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)
measure: Progression Free Survival (PFS)
time frame: the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
description: Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored
measure: Objective Response Rate
time frame: Up to 3 years
description: All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.
measure: Disease Control Rate (DCR)
time frame: Up to 3 years
description: Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.
measure: Rate of Resectability (RR)
time frame: Up to 3 years
description: Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.
measure: Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).
time frame: Up to 3 years
description: Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).
arm group label: FOLFIRINOX
arm group type: Experimental
description: FOLFIRINOX given to all subjects
intervention type: Drug
intervention name: FOLFIRINOX
description: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
Oxaliplatin (85 mg/m2)
Leucovorin (400mg/ m2)
Irinotecan (180 mg/m2)
5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours
arm group label: FOLFIRINOX
other name: FOLFIRINOX is a chemotherapy regimen comprised of the following drugs, given in combination
other name: -Oxaliplatin
other name: -Leucovorin
other name: -Irinotecan
other name: -5FU
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Autumn J McRee, MD
role: Principal Investigator
affiliation: University of North Carolina
facility: 
country: United States
url: http://unclineberger.org/
description: UNC Lineberger Comprehensive Cancer Center homepage
url: http://www.cancer.gov/
description: National Cancer Institute (NCI) homepage
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
mesh term: Leucovorin
mesh term: Oxaliplatin
mesh term: Irinotecan
mesh term: Folfirinox
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 