<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/NCT01677884</url>
  </required_header>
  <id_info>
    <org_study_id>2011-005559-15</org_study_id>
    <secondary_id>CSET 2011/1827</secondary_id>
    <nct_id>NCT01677884</nct_id>
  </id_info>
  <brief_title>Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy</brief_title>
  <acronym>BEVIAC</acronym>
  <official_title>Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy in Hepatic Metastases of Metastatic Colorectal Cancer: a Phase II Multicentric Study With Patients in Progression After First Line Systemic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gustave Roussy, Cancer Campus, Grand Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gustave Roussy, Cancer Campus, Grand Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assessed the efficiency of treatment based on the objective&#xD;
      response rate (RECIST 1.1)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 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>Efficiency of treatment based on objective response rate</measure>
    <time_frame>Every 9 weeks from the start to tumoral progression</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment toxicity based on NCI-CTC v4.0</measure>
    <time_frame>Every 3 weeks from the start to tumoral progression or toxicity preventing further processing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Every 9 weeks form the start to tumoral progression</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic metastasis resection rate</measure>
    <time_frame>Assessed up 6 months after the end of treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Total area under the curve of contrast-enhanced liver ultrasound</measure>
    <time_frame>Assessed up in baseline, D7, D14, W4, W7 and every 9 weeks up to progression</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <arm_group>
    <arm_group_label>Patients with metastatic CRC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1</description>
    <arm_group_label>Patients with metastatic CRC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4</description>
    <arm_group_label>Patients with metastatic CRC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Irinotecan</intervention_name>
    <description>Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)</description>
    <arm_group_label>Patients with metastatic CRC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Liver metastases of colon cancer or rectal predominant (histological evidence obtained&#xD;
             on the primary tumor or liver metastases)&#xD;
&#xD;
               -  Isolated (no extra-hepatic metastasis, primary tumor resected)&#xD;
&#xD;
               -  No access to curative hepatectomy (R0 resection foreseeable or not leaving less&#xD;
                  than 30% residual non-tumor liver normally vascularized), or requiring complex&#xD;
                  hepatectomy, very large (5 or more segments) and / or risked (class II CPP)&#xD;
&#xD;
               -  which at least one measurable by RECIST (&gt;2 cm, or &gt;1 cm if Computed tomography&#xD;
                  (CT) spiraled)&#xD;
&#xD;
               -  Or extra-hepatic disease of small size potentially accessible to a resection (one&#xD;
                  or two lung metastases, lymphadenopathy localized accessible to curative&#xD;
                  resection)&#xD;
&#xD;
               -  colon or rectal primary tumor : resected or asymptomatic&#xD;
&#xD;
          -  Progression after first line chemotherapy to treat the metastatic disease, all types&#xD;
             of treatment allowed except intra-arterial Bevacizumab&#xD;
&#xD;
          -  Age &gt;18 years &lt;75 years&#xD;
&#xD;
          -  Performance status WHO 0 or 1&#xD;
&#xD;
          -  Life expectancy &gt;3 months&#xD;
&#xD;
          -  Bilirubin &lt;1.5 times the upper limit of normal (N), ASAT and ALAT &lt;5N, creatinine &lt;1.5&#xD;
             N neutrophils &gt;1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin &gt;9g/dL. Patients may&#xD;
             be included even if they were transfused&#xD;
&#xD;
          -  CT (or MRI) reference for the measurement of metastases performed within 28 days&#xD;
             before the first treatment cycle&#xD;
&#xD;
          -  Information of the patient or legal representative signing the informed consent&#xD;
&#xD;
          -  Affiliated to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic colon or rectal primary tumor (sub-occlusion, significant hemorrhage,&#xD;
             major rectal syndrome)&#xD;
&#xD;
          -  Extra-hepatic metastases other than small size disease potentially accessible after&#xD;
             resection&#xD;
&#xD;
          -  Grade 3-4 allergy to one of the treatment compounds&#xD;
&#xD;
          -  Two lines of prior chemotherapy. One line is allowed for metastatic disease but must&#xD;
             have been started more than 6 months after completion of adjuvant treatment.&#xD;
&#xD;
          -  Participation during or within 30 days before study to another therapeutic trial with&#xD;
             an experimental molecule&#xD;
&#xD;
          -  Concomitant cancer systemic treatment using immunotherapy, chemotherapy or hormone&#xD;
&#xD;
          -  Symptomatic CHD or myocardial infarction within 6 months prior entry into the study,&#xD;
             cardiac arrhythmia uncontrolled despite treatment&#xD;
&#xD;
          -  Uncontrolled hypertension (blood pressure &gt;150/100 mm Hg despite hypertensive&#xD;
             treatment)&#xD;
&#xD;
          -  Heart Failure &gt;Grade II of the New York Heart Association (NYHA) (class&#xD;
             II-III-IV)severe renal failure&#xD;
&#xD;
          -  History and / or presence of bleeding disorders and/or thrombotic &lt;6 months&#xD;
&#xD;
          -  Uncontrolled Serious illness, uncontrolled active infection or other serious&#xD;
             underlying condition which may prevent the patient to receive treatment&#xD;
&#xD;
          -  Pregnancy (or positive pregnancy test at baseline), lactation or no contraception&#xD;
             effective for men or women of childbearing age&#xD;
&#xD;
          -  Occlusion or sub-bowel obstruction or history of inflammatory bowel disease&#xD;
&#xD;
          -  Other cancer within 5 years prior to entry into the trial or concomitant (except in&#xD;
             situ cancer of the cervix or skin basal-cell carcinoma properly treated)&#xD;
&#xD;
          -  Legal inability (persons deprived of liberty or under guardianship)&#xD;
&#xD;
          -  Inability to sign the consent or submit to medical test for geographical, social or&#xD;
             psychological reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michel Ducreux, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gustave Roussy, Cancer Campus, Grand Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>June 8, 2016</last_update_submitted>
  <last_update_submitted_qc>June 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Irinotecan</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/NCT01677884
org study id: 2011-005559-15
secondary id: CSET 2011/1827
nct id: NCT01677884
lead sponsor: 
has dmc: Yes
The purpose of the study is to assessed the efficiency of treatment based on the objective
      response rate (RECIST 1.1)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficiency of treatment based on objective response rate
time frame: Every 9 weeks from the start to tumoral progression
measure: Treatment toxicity based on NCI-CTC v4.0
time frame: Every 3 weeks from the start to tumoral progression or toxicity preventing further processing
measure: Progression Free Survival
time frame: Every 9 weeks form the start to tumoral progression
measure: Hepatic metastasis resection rate
time frame: Assessed up 6 months after the end of treatment
measure: Total area under the curve of contrast-enhanced liver ultrasound
time frame: Assessed up in baseline, D7, D14, W4, W7 and every 9 weeks up to progression
arm group label: Patients with metastatic CRC
arm group type: Experimental
intervention type: Drug
intervention name: Bevacizumab
description: Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
arm group label: Patients with metastatic CRC
intervention type: Drug
intervention name: Capecitabine
description: Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
arm group label: Patients with metastatic CRC
intervention type: Drug
intervention name: Irinotecan
description: Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)
arm group label: Patients with metastatic CRC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michel Ducreux, MD-PhD
role: Principal Investigator
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Bevacizumab
mesh term: Capecitabine
mesh term: Irinotecan