<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/NCT01705184</url>
  </required_header>
  <id_info>
    <org_study_id>IFCT-1102</org_study_id>
    <secondary_id>2012-002647-18</secondary_id>
    <nct_id>NCT01705184</nct_id>
  </id_info>
  <brief_title>Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.</brief_title>
  <acronym>BUCiL</acronym>
  <official_title>Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intergroupe Francophone de Cancerologie Thoracique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intergroupe Francophone de Cancerologie Thoracique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with&#xD;
      platinum eventually associated with bevacizumab. A new treatment begins at progression.&#xD;
&#xD;
      In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could&#xD;
      be administered according to a stop and go strategy respecting therapeutic breaks between&#xD;
      sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance&#xD;
      is possibly better than an absence of treatment. These plans benefit to the patients in terms&#xD;
      of efficiency but also in terms of toxicity, in particular neurological.&#xD;
&#xD;
      The question is to know if this strategy is feasible in lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">January 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>Feasibility</measure>
    <time_frame>After 3 cycles</time_frame>
    <description>Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Control rate after the 2nd sequence</measure>
    <time_frame>After 3 cycles</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate after the 1st sequence</measure>
    <time_frame>After 3 cycles</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>During Sequence 2 : at the beginning and after 3 cycles</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Non-small Cell Lung Cancer Metastatic</condition>
  <condition>Nonsquamous Nonsmall Cell Neoplasm of Lung</condition>
  <arm_group>
    <arm_group_label>BUCiL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --&gt; Sequence 2&#xD;
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence</description>
    <arm_group_label>BUCiL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence</description>
    <arm_group_label>BUCiL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.</description>
    <arm_group_label>BUCiL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non squamous non small cell lung cancer histologically or cytologically confirmed with&#xD;
             no EGFR mutation.&#xD;
&#xD;
          -  Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is&#xD;
             asymptomatic.&#xD;
&#xD;
          -  Measurable disease (recist criteria)&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  PS0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated&#xD;
             cancer&#xD;
&#xD;
          -  History of malignant tumour excepted cervical and basocellular cancer and cancer cured&#xD;
             for at least 5 years.&#xD;
&#xD;
          -  Tumor invaded the big vessels or the proximal visible in TDM.&#xD;
&#xD;
          -  History of adjuvant or neoadjuvant chemotherapy&#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>Jaafar BENNOUNA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre René Gauducheau - Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avignon - Institut Sainte-Catherine</name>
      <address>
        <city>Avignon</city>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caen - Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caen - CHU Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier</name>
      <address>
        <city>Chauny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH du Mans</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord - Oncologie Multidisciplinaire &amp; Innovations Thérapeutiques</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mulhouse - CH</name>
      <address>
        <city>Mulhouse</city>
        <zip>68000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes - Centre René Gauducheau</name>
      <address>
        <city>Nantes</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Tenon - Pneumologie</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL - Lyon Sud (Pneumologie)</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rennes - CHU</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strasbourg - NHC</name>
      <address>
        <city>Strasbourg</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.ifct.fr</url>
    <description>IFCT website</description>
  </link>
  <reference>
    <citation>Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.</citation>
    <PMID>16421419</PMID>
  </reference>
  <reference>
    <citation>Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.</citation>
    <PMID>22341744</PMID>
  </reference>
  <reference>
    <citation>Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.</citation>
    <PMID>19786657</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stop and go</keyword>
  <keyword>Non-small cell lung cancer</keyword>
  <keyword>Non-squamous</keyword>
  <keyword>Bevacizumab</keyword>
  <keyword>IFCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Pemetrexed</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/NCT01705184
org study id: IFCT-1102
secondary id: 2012-002647-18
nct id: NCT01705184
lead sponsor: 
has dmc: No
At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with
      platinum eventually associated with bevacizumab. A new treatment begins at progression.

      In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could
      be administered according to a stop and go strategy respecting therapeutic breaks between
      sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance
      is possibly better than an absence of treatment. These plans benefit to the patients in terms
      of efficiency but also in terms of toxicity, in particular neurological.

      The question is to know if this strategy is feasible in lung cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility
time frame: After 3 cycles
description: Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
measure: Control rate after the 2nd sequence
time frame: After 3 cycles
measure: Response rate after the 1st sequence
time frame: After 3 cycles
measure: Overall survival
time frame: 12 months
measure: Quality of life
time frame: During Sequence 2 : at the beginning and after 3 cycles
arm group label: BUCiL
arm group type: Experimental
description: Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --> Sequence 2
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
intervention type: Drug
intervention name: Cisplatin
description: 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
arm group label: BUCiL
intervention type: Drug
intervention name: Bevacizumab
description: 7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
arm group label: BUCiL
intervention type: Drug
intervention name: Pemetrexed
description: 500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
arm group label: BUCiL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jaafar BENNOUNA, MD
role: Principal Investigator
affiliation: Centre René Gauducheau - Nantes
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
url: http://www.ifct.fr
description: IFCT website
citation: Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.
PMID: 16421419
citation: Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.
PMID: 22341744
citation: Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.
PMID: 19786657
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Bevacizumab
mesh term: Pemetrexed