<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/NCT02215720</url>
  </required_header>
  <id_info>
    <org_study_id>2010-012275-88</org_study_id>
    <secondary_id>2010/1626</secondary_id>
    <nct_id>NCT02215720</nct_id>
  </id_info>
  <brief_title>Temsirolimus and Cetuximab in Patients With Advanced or Metastatic Solid Tumors</brief_title>
  <acronym>TORERO</acronym>
  <official_title>Phase I Study of Temsirolimus and Cetuximab in Adults Patients With Advanced or Metastatic Solid Tumors</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal&#xD;
      cancer or head and neck cancer in several phase II/III studies.&#xD;
&#xD;
      Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II&#xD;
      studies in advance kidney cancer of bad prognosis.&#xD;
&#xD;
      Study hypothesis is that combination of those two compounds and the inhibition of two&#xD;
      pathways at the same time will have more efficiency on tumoral growth than the inhibition of&#xD;
      those pathways in isolation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</primary_completion_date>
  <phase>Phase 1</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>Safety</measure>
    <time_frame>Assessed every every week from inclusion during the four first weeks then at week 8 then every 2 months until death or progression whichever comes first up to 24 months</time_frame>
    <description>Adverse effects will be assessed using NCI-CTC.AE v.4</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>Assessed every 2 cycles (44 days) from inclusion up to 24 months</time_frame>
    <description>Tumorous response will be assessed using RECIST criteria</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Patients With Advanced or Metastatic Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Cetuximab + Temsirolimus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <arm_group_label>Cetuximab + Temsirolimus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Temsirolimus</intervention_name>
    <arm_group_label>Cetuximab + Temsirolimus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with malignant tumor confirmed histologically or cytologically who does not&#xD;
             respond to usual therapeutics or for whom there is no curative treatment&#xD;
&#xD;
          -  Age &gt;/= 18 years&#xD;
&#xD;
          -  ECOG 0 or 1&#xD;
&#xD;
          -  Life expectancy &gt;/= 12 weeks&#xD;
&#xD;
          -  Grade &lt;/=1 for all adverse effects related to previous therapy or surgery (except for&#xD;
             alopecia)&#xD;
&#xD;
          -  Appropriate organic functions as defined:&#xD;
&#xD;
          -  ASAT and ALAT &lt;/= 2.5xLSN or ASAT and ALAT &lt;/= 5xLSN in case of inappropriate hepatic&#xD;
             function due to the underlying disease&#xD;
&#xD;
          -  Bilirubin &lt;/= 1.5xLSN&#xD;
&#xD;
          -  Albumin &gt;/= 3.0 g/dL&#xD;
&#xD;
          -  Neutrophil counts (PNN) &gt;/= 1 500/mL&#xD;
&#xD;
          -  Platelets &gt;/= 100 000/mL&#xD;
&#xD;
          -  Hemoglobin &gt;/= 9.0 g/dL&#xD;
&#xD;
          -  Creatinin &lt;/= 1.5xLSN&#xD;
&#xD;
          -  Cooperative patients able to respect the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment by chemotherapy, radiotherapy, surgery or the two compounds of the study&#xD;
             within 4 weeks before the inclusion&#xD;
&#xD;
          -  Previous treatment with an association of mTOR inhibitor or EGFR inhibitor&#xD;
&#xD;
          -  Diagnosis of a secondary cancer within the last 3 years except for a basal-cell&#xD;
             carcinoma, cutaneous spinocellular cancer or in situ carcinoma well treated&#xD;
&#xD;
          -  Grade &gt;/= 2 nephropathy according to NCI CTCAE&#xD;
&#xD;
          -  Current treatment with curative dose of coumadin or heparin of low molecular weight&#xD;
&#xD;
          -  Previous uncontrolled brain metastases, medullar compression or carcinomatosis&#xD;
             meningitis or any proof of leptomeningeal pathology or metastasis.&#xD;
&#xD;
          -  Presence of one og those pathologies during the last 12 months before the inclusion:&#xD;
&#xD;
          -  myocardial infarction&#xD;
&#xD;
          -  angina pectoris&#xD;
&#xD;
          -  bypass of coronal or peripheral arteries&#xD;
&#xD;
          -  heart failure&#xD;
&#xD;
          -  stroke&#xD;
&#xD;
          -  cerebral bleeding&#xD;
&#xD;
          -  pulmonary embolism&#xD;
&#xD;
          -  Grade 3 bleeding according to NCI CTCAE criteria less than 3 weeks before treatment&#xD;
             start&#xD;
&#xD;
          -  Uncontrolled high blood pressure (&gt;150/100mhHg)&#xD;
&#xD;
          -  Grade &gt;/=2 heart rate disorder, atrial fibrillation whichever the grade, lengthen of&#xD;
             QTC &gt;450 msec for male or &gt;470 msec for female.&#xD;
&#xD;
          -  Patients HIV positive&#xD;
&#xD;
          -  Pregnant or breastfeeding woman&#xD;
&#xD;
          -  Patients with psychiatric disorder&#xD;
&#xD;
          -  Active alcoholism&#xD;
&#xD;
          -  Previous pulmonary interstitial disease&#xD;
&#xD;
          -  Previous hypersensitivity to antihistamine treatment and/or medical contraindication&#xD;
             for an antihistamine or corticoid treatment&#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_contact>
    <last_name>SORIA Jean Charles, MD, PhD</last_name>
    <phone>0142114291</phone>
    <phone_ext>+33</phone_ext>
    <email>jean-charles.soria@gustaveroussy.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>HASSELBERG Rudiger, MD,PhD</last_name>
    <phone>0142116250</phone>
    <phone_ext>+33</phone_ext>
    <email>rudgier.hasselberg@gustaveroussy.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <state>Val de Marne</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rudiger HASSELBERG</last_name>
      <phone>0142116250</phone>
      <phone_ext>+33</phone_ext>
      <email>rudiger.hasselberg@gustaveroussy.fr</email>
    </contact>
    <investigator>
      <last_name>Jean Charles SORIA, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>February 9, 2016</last_update_submitted>
  <last_update_submitted_qc>February 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 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>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Cetuximab</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>MTOR Inhibitors</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/NCT02215720
org study id: 2010-012275-88
secondary id: 2010/1626
nct id: NCT02215720
lead sponsor: 
has dmc: No
Cetuximab is an EGFR inhibitor that has shown efficacy alone or in combination in colorectal
      cancer or head and neck cancer in several phase II/III studies.

      Temsirolimus is a new mTOR inhibitor that has shown interesting results in several Phase I/II
      studies in advance kidney cancer of bad prognosis.

      Study hypothesis is that combination of those two compounds and the inhibition of two
      pathways at the same time will have more efficiency on tumoral growth than the inhibition of
      those pathways in isolation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: Assessed every every week from inclusion during the four first weeks then at week 8 then every 2 months until death or progression whichever comes first up to 24 months
description: Adverse effects will be assessed using NCI-CTC.AE v.4
measure: Efficacy
time frame: Assessed every 2 cycles (44 days) from inclusion up to 24 months
description: Tumorous response will be assessed using RECIST criteria
arm group label: Cetuximab + Temsirolimus
arm group type: Experimental
description: Cetuximab: 400mg/m² IV for 120 minutes Temsirolimus: 15mg IV for 60 minutes
intervention type: Drug
intervention name: Cetuximab
arm group label: Cetuximab + Temsirolimus
intervention type: Drug
intervention name: Temsirolimus
arm group label: Cetuximab + Temsirolimus
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: SORIA Jean Charles, MD, PhD
phone: 0142114291
phone ext: +33
email: jean-charles.soria@gustaveroussy.fr
last name: HASSELBERG Rudiger, MD,PhD
phone: 0142116250
phone ext: +33
email: rudgier.hasselberg@gustaveroussy.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Sirolimus
mesh term: Cetuximab
mesh term: Temsirolimus
mesh term: MTOR Inhibitors