<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/NCT01706120</url>
  </required_header>
  <id_info>
    <org_study_id>MITO-16 - MANGO-OV2</org_study_id>
    <secondary_id>2012-003043-29</secondary_id>
    <nct_id>NCT01706120</nct_id>
  </id_info>
  <brief_title>Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab</brief_title>
  <acronym>MITO16/MANGO-2</acronym>
  <official_title>A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute, Naples</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mario Negri Institute for Pharmacological Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cancer Institute, Naples</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The addition of bevacizumab to first-line chemotherapy has been shown to improve progression&#xD;
      free survival for patients with ovarian cancer. The purpose of this study is to explore the&#xD;
      potential role of clinical and biologic factors in identifying those patients who benefit&#xD;
      most from this combined therapy in terms of progression free and overall survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV&#xD;
      study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as&#xD;
      first line treatment (in-label dose and scheduling). This is an exploratory study attempting&#xD;
      to identify potential prognostic clinical factors(such as hypertension) and prognostic&#xD;
      biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those&#xD;
      expressing the changing nature of the disease in relation to the treatment or simply the&#xD;
      tumour progression, these are typically not inherited. Genetic biomarkers are typically&#xD;
      inherited and are expression of some characteristics potentially able to interfere with the&#xD;
      treatment effect (i.e. Pharmacogenomics).&#xD;
&#xD;
      The safety of this regimen in routine clinical practice will also be described.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 4</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>expression of soluble and tissutal biomarkers</measure>
    <time_frame>measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>one year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>worst grade toxicity per patient</measure>
    <time_frame>evaluated every 3 weeks up to 15 month</time_frame>
    <description>according to Common Toxicity Criteria for Adverse Events v. 4.03</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients taking oral antidiabetic therapy</measure>
    <time_frame>at baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients taking antithrombotic therapy</measure>
    <time_frame>at baseline</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>First-line chemotherapy with bevacizumab</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles&#xD;
Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles&#xD;
Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles</description>
    <arm_group_label>First-line chemotherapy with bevacizumab</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles</description>
    <arm_group_label>First-line chemotherapy with bevacizumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>• Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles</description>
    <arm_group_label>First-line chemotherapy with bevacizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients ≥18 years of age.&#xD;
&#xD;
          -  Patients with histologically confirmed epithelial ovarian carcinoma, fallopian tube&#xD;
             carcinoma or primary peritoneal carcinoma, including mixed Mullerian Tumours Or&#xD;
             Recurrent early stage epithelial ovarian or fallopian tube carcinoma treated with&#xD;
             surgery alone.&#xD;
&#xD;
          -  FIGO stage IIIB &amp; C or IV&#xD;
&#xD;
          -  ECOG Performance Status of 0-2.&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks.&#xD;
&#xD;
          -  Signed informed consent obtained prior to initiation of any study-specific procedures&#xD;
             and treatment as confirmation of the patient's awareness and willingness to comply&#xD;
             with the study requirements.&#xD;
&#xD;
          -  Availability of tumour samples for molecular analyses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cancer related&#xD;
&#xD;
          -  Ovarian tumours with low malignant potential (i.e. borderline tumours)&#xD;
&#xD;
          -  Previous systemic anti-cancer therapy for advanced ovarian cancer.&#xD;
&#xD;
          -  History or evidence of brain metastases or spinal cord compression.&#xD;
&#xD;
          -  History or evidence of synchronous primary endometrial carcinoma, unless all of the&#xD;
             following criteria related to the endometrial carcinoma are met:&#xD;
&#xD;
               -  stage ≤Ia&#xD;
&#xD;
               -  no more than superficial myometrial invasion&#xD;
&#xD;
               -  no lymphovascular invasion&#xD;
&#xD;
               -  not poorly differentiated (grade 3 or papillary serous or clear cell carcinoma).&#xD;
&#xD;
          -  Other malignancy within the last 5 years, except for adequately treated carcinoma in&#xD;
             situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited&#xD;
             basal cell skin cancer.&#xD;
&#xD;
        Other-treatment related&#xD;
&#xD;
          -  Any prior radiotherapy to the pelvis or abdomen.&#xD;
&#xD;
          -  Surgery (including open biopsy) within 4 weeks prior to the first bevacizumab dose or&#xD;
             planned (In this case the patient can be enrolled but the administration of&#xD;
             bevacizumab should be omitted at first cycle).&#xD;
&#xD;
          -  Current or recent (within 10 days prior to the first study drug dose) use of full-dose&#xD;
             oral or parenteral anticoagulant or thrombolytic agent for therapeutic purposes&#xD;
             (except for central venous access patency, in which case international normalized&#xD;
             ratio [INR] must be maintained below 1.5). Post operative prophylaxis with low&#xD;
             molecular weight heparin sc is allowed.&#xD;
&#xD;
          -  Current or recent (within 30 days of first study dosing) treatment with another&#xD;
             investigational drug.&#xD;
&#xD;
        Laboratory related&#xD;
&#xD;
          -  Inadequate bone marrow function: ANC: &lt;1.5 x 109/l, or platelet count &lt;100 x 109/l or&#xD;
             Haemoglobin &lt;9 g/dl. Patients may be transfused to maintain haemoglobin values ≥9&#xD;
             g/dl.&#xD;
&#xD;
          -  Inadequate coagulation parameters:&#xD;
&#xD;
               -  activated partial thromboplastin time (APTT) &gt;1.5 xULN or&#xD;
&#xD;
               -  INR &gt;1.5&#xD;
&#xD;
          -  Inadequate liver function, defined as:&#xD;
&#xD;
               -  serum (total) bilirubin &gt;1.5 x the upper limit of normal (ULN) for the&#xD;
                  institution&#xD;
&#xD;
               -  AST/SGOT or ALT/SGPT &gt;2.5 x ULN.&#xD;
&#xD;
          -  Inadequate renal function, defined as serum creatinine &gt;2.0 mg/dl or &gt;177 micromol/l&#xD;
&#xD;
          -  Proteinuria &gt;1g in a 24-hour urine collection (to be performed only among patients who&#xD;
             showed a ≥3+ at urine dipstick).&#xD;
&#xD;
        Patient related&#xD;
&#xD;
          -  Pregnant or lactating patients.&#xD;
&#xD;
          -  History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular&#xD;
             accident (CVA) / stroke or transient ischemic attack (TIA) or sub-arachnoid&#xD;
             haemorrhage within ≤6 months prior to the first study treatment).&#xD;
&#xD;
          -  Uncontrolled hypertension (sustained systolic &gt;150 mm Hg and/or diastolic &gt;100 mm Hg&#xD;
             despite antihypertensive therapy) or clinically significant (i.e. active)&#xD;
             cardiovascular disease, including:&#xD;
&#xD;
               -  myocardial infarction or unstable angina within ≤6 months prior to the first&#xD;
                  study treatment&#xD;
&#xD;
               -  New York Heart Association (NYHA) grade II or greater congestive heart failure&#xD;
                  (CHF)&#xD;
&#xD;
               -  serious cardiac arrhythmia requiring medication (with the exception of atrial&#xD;
                  fibrillation or paroxysmal supraventricular tachycardia)&#xD;
&#xD;
               -  peripheral vascular disease ≥grade 3 (i.e. symptomatic and interfering with&#xD;
                  activities of daily living requiring repair or revision).&#xD;
&#xD;
          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess&#xD;
             within 6 months prior to the first study treatment.&#xD;
&#xD;
          -  Non-healing wound, ulcer or bone fracture. Patients with granulating incisions healing&#xD;
             by secondary intention with no evidence of fascial dehiscence or infection are&#xD;
             eligible but require three weekly wound examinations.&#xD;
&#xD;
          -  Evidence of any other medical conditions (such as psychiatric illness, peptic ulcer,&#xD;
             etc.), physical examination or laboratory findings that may interfere with the planned&#xD;
             treatment, affect patient compliance or place the patient at high risk from&#xD;
             treatment-related complications.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandro Pignata, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute, Naples</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicoletta Colombo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>European Institute of Oncology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesco Perrone, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute, Naples</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gennaro Daniele, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute, Naples</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Roldano Fossati, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mario Negri Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ciro Gallo, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Irene Floriani, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mario Negri Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>A.S.O. SS Antonio e Biagio e Cesare Arrigo</name>
      <address>
        <city>Alessandria</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro di Riferimento Oncologico</name>
      <address>
        <city>Aviano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Fatebenefratelli</name>
      <address>
        <city>Benevento</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spedali Civili - Università di Brescia</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Senatore Antonio Perrino</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione del Piemonte per l'Oncologia</name>
      <address>
        <city>Candiolo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ramazzini di Carpi /Ospedale di Mirandola</name>
      <address>
        <city>Carpi</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Garibaldi Nesimadi Catania</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Cannizzaro</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mater Domini</name>
      <address>
        <city>Catanzaro</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile di Faenza</name>
      <address>
        <city>Faenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Croce</name>
      <address>
        <city>Fano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Arcispedale Sant'Anna di Ferrara</name>
      <address>
        <city>Ferrara</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Fabrizio Spaziani di Frosinone / Osp. SS Trinità di Sora</name>
      <address>
        <city>Frosinone</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>E.O. Ospedali Galliera</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS San Martino IST</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Guastalla</name>
      <address>
        <city>Guastalla</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale A. Manzoni</name>
      <address>
        <city>Lecco</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mater Salutis</name>
      <address>
        <city>Legnago</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Manerbio</name>
      <address>
        <city>Manerbio</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. C. Poma</name>
      <address>
        <city>Mantova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Romagnolo per lo Studio e la Cura dei Tumori</name>
      <address>
        <city>Meldola</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori</name>
      <address>
        <city>MIlano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.L.S.S. 13</name>
      <address>
        <city>Mirano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico Modena</name>
      <address>
        <city>Modena</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Gerardo</name>
      <address>
        <city>Monza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico Federico II</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale dei Tumori</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Sacro Cuore Don Calabria</name>
      <address>
        <city>Negrar</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Oncologico Veneto</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS S. Matteo</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Silvestrini</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Chiara</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Santa Maria degli Angeli</name>
      <address>
        <city>Pordenone</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Maria delle Croci</name>
      <address>
        <city>Ravenna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arcispedale S. Maria Nuova</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale degli Infermi / Ospedale Civile</name>
      <address>
        <city>Rimini</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Regina Elena</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale S. Giovanni Calibita Fatebenefratelli</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Ordine Mauriziano</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. OIRM-S. Anna</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASS N 1 Triestina</name>
      <address>
        <city>Trieste</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. di Udine S. Maria delle Misericordia</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale del Ponte</name>
      <address>
        <city>Varese</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prognostic factors</keyword>
  <keyword>biologic factors</keyword>
  <keyword>clinical factors</keyword>
  <keyword>routine clinical practice</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</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/NCT01706120
org study id: MITO-16 - MANGO-OV2
secondary id: 2012-003043-29
nct id: NCT01706120
lead sponsor: 
collaborator: 
has dmc: No
The addition of bevacizumab to first-line chemotherapy has been shown to improve progression
      free survival for patients with ovarian cancer. The purpose of this study is to explore the
      potential role of clinical and biologic factors in identifying those patients who benefit
      most from this combined therapy in terms of progression free and overall survival.
MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV
      study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as
      first line treatment (in-label dose and scheduling). This is an exploratory study attempting
      to identify potential prognostic clinical factors(such as hypertension) and prognostic
      biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those
      expressing the changing nature of the disease in relation to the treatment or simply the
      tumour progression, these are typically not inherited. Genetic biomarkers are typically
      inherited and are expression of some characteristics potentially able to interfere with the
      treatment effect (i.e. Pharmacogenomics).

      The safety of this regimen in routine clinical practice will also be described.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: expression of soluble and tissutal biomarkers
time frame: measured at baseline, at completion of chemotherapy, at disease progression or bevacizumab completion up to 15 monthsfor each patient
measure: progression free survival
time frame: one year
measure: overall survival
time frame: three years
measure: worst grade toxicity per patient
time frame: evaluated every 3 weeks up to 15 month
description: according to Common Toxicity Criteria for Adverse Events v. 4.03
measure: number of patients taking oral antidiabetic therapy
time frame: at baseline
measure: number of patients taking antithrombotic therapy
time frame: at baseline
arm group label: First-line chemotherapy with bevacizumab
arm group type: Other
description: Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks for up to 22 cycles
Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles
Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
intervention type: Drug
intervention name: Bevacizumab
description: • Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles
arm group label: First-line chemotherapy with bevacizumab
other name: Avastin
intervention type: Drug
intervention name: Paclitaxel
description: • Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles
arm group label: First-line chemotherapy with bevacizumab
intervention type: Drug
intervention name: Carboplatin
description: • Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
arm group label: First-line chemotherapy with bevacizumab
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sandro Pignata, M.D., Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute, Naples
last name: Nicoletta Colombo, M.D.
role: Principal Investigator
affiliation: European Institute of Oncology
last name: Francesco Perrone, M.D., Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute, Naples
last name: Gennaro Daniele, M.D., Ph.D.
role: Principal Investigator
affiliation: National Cancer Institute, Naples
last name: Roldano Fossati, M.D.
role: Principal Investigator
affiliation: Mario Negri Institute
last name: Ciro Gallo, M.D.
role: Principal Investigator
affiliation: University of Campania "Luigi Vanvitelli"
last name: Irene Floriani, Ph.D.
role: Principal Investigator
affiliation: Mario Negri Institute
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country: Italy
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel
mesh term: Bevacizumab
mesh term: Carboplatin