<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/NCT01735071</url>
  </required_header>
  <id_info>
    <org_study_id>IRFMN-OVA-6152</org_study_id>
    <nct_id>NCT01735071</nct_id>
  </id_info>
  <brief_title>Bevacizumab and Trabectedin +/- Carboplatin in Advanced Ovarian Cancer</brief_title>
  <official_title>Multicenter, Randomized, Non-comparative, Phase II Trial on the Efficacy and Safety of the Combination of Bevacizumab and Trabectedin With or Without Carboplatin in Adult Women With Platinum Partially Sensitive Recurring Ovarian Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mario Negri Institute for Pharmacological Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PharmaMar</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mario Negri Institute for Pharmacological Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is aimed at assessing the efficacy and the safety of the combination of&#xD;
      bevacizumab and trabectedin with or without carboplatin in adult women with epithelial&#xD;
      ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or&#xD;
      second) platinum-containing regimen. According to the Bryant and Day design the primary&#xD;
      endpoints will be the proportion of progression-free patients at 6 months for the efficacy,&#xD;
      and the proportion of patients with severe toxicity for the safety at the same time-point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2013</start_date>
  <completion_date type="Actual">March 18, 2018</completion_date>
  <primary_completion_date type="Actual">March 18, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a multicentre, randomized, non-comparative phase II study aimed at assessing efficacy and safety of two regimens according to a Bryant and Day two-stage design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival at 6 months (PFS-6)</measure>
    <time_frame>from randomization up to 6 months</time_frame>
    <description>The PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients with severe toxicity within 6 months from randomization.</measure>
    <time_frame>from randomization up to 6 months</time_frame>
    <description>The following conditions will be considered as severe toxicity:&#xD;
absolute neutrophil count (ANC) &lt; 0.5x109/L lasting &gt; 7 days and/or with fever&#xD;
platelets &lt; 25x109/L&#xD;
any other grade 3-4 (evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.0) non-hematological toxicities except for reversible nausea/vomiting, diarrhea, hypersensitivity reactions, and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation reversible to grade 1 by day 28&#xD;
any toxicity causing a delay of &gt;14 days in the following cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death for any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival at 12 months (OS-12)</measure>
    <time_frame>one year</time_frame>
    <description>Defined as the percentage of patients who are alive at 12 months after the randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit (CB)</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>clinical benefit, defined as the percentage of patients who are judged by the Investigators to have a complete response (CR), or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, version 1.1 after 12 weeks from the date of randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events (AEs)</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Incidence of AEs, according to NCI-CTCAE, version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum toxicity grade</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Maximum toxicity grade experienced by each patient for each specific toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with at least a Serious Adverse Drug Reaction (SADR)</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Patients with at least a SADR during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with at least a Suspect Unexpected Serious Adverse Reaction (SUSAR).</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Patients with at least a suspect unexpected serious adverse reaction during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with dose and/or time modifications</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Percentage of patients with dose and/or time modifications of the study drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of premature withdrawals</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Percentage of premature withdrawals of the enrolled patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients with at least a Serious Adverse Event (SAE)</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Patients with at least a SAE during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nature of AEs</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Nature of AEs, according to NCI-CTCAE, version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AEs</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Severity of AEs, according to NCI-CTCAE, version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seriousness of AEs</measure>
    <time_frame>from randomization up to 30 months</time_frame>
    <description>Seriousness of AEs according to NCI-CTCAE, version 4.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Ovarian Epithelial Cancer Recurrent</condition>
  <arm_group>
    <arm_group_label>bevacizumab and trabectedin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bevacizumab, trabectedin and carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm B: cycle 1-6, bevacizumab given as 1 hour infusion will be followed by carboplatin area under curve 4 (AUC 4) and trabectedin 3 hour iv infusion.&#xD;
Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.&#xD;
Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.&#xD;
From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bevacizumab and trabectedin</intervention_name>
    <description>Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients</description>
    <arm_group_label>bevacizumab and trabectedin</arm_group_label>
    <other_name>Avastin</other_name>
    <other_name>Yondelis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>bevacizumab, trabectedin and carboplatin</intervention_name>
    <description>Arm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion.&#xD;
Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.&#xD;
Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.&#xD;
From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days</description>
    <arm_group_label>bevacizumab, trabectedin and carboplatin</arm_group_label>
    <other_name>Avastin</other_name>
    <other_name>Yondelis</other_name>
    <other_name>Carboplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age≥18years&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG)- performance status 0-2&#xD;
&#xD;
          -  Cytological/histological diagnosis of epithelial ovarian cancer&#xD;
&#xD;
          -  Progression free interval between 6-12 months (calculated from the first day of the&#xD;
             last cycle of the previous last platinum-based chemotherapy until the date of&#xD;
             progression confirmation through radiologic imaging)&#xD;
&#xD;
          -  One or two previous platinum-based chemotherapy lines&#xD;
&#xD;
          -  Measurable disease according to RECIST version 1.1&#xD;
&#xD;
          -  Life expectancy ≥ 12 weeks&#xD;
&#xD;
          -  Patients must be able to receive dexamethasone or its equivalent, as a premedication&#xD;
             for trabectedin&#xD;
&#xD;
          -  Written informed consents given before the enrolment according to International&#xD;
             Conference on Harmonization/ Good Clinical Practice (ICH/GCP).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with trabectedin&#xD;
&#xD;
          -  Prior progression while on therapy containing bevacizumab or other vascular&#xD;
             endothelial growth factor (VEGF) pathway-target therapy&#xD;
&#xD;
          -  Pre-existing grade &gt; 1 sensitive/motor neurologic disorder&#xD;
&#xD;
          -  Current or recent (within 30 days of first study dosing) treatment with another&#xD;
             investigational drug&#xD;
&#xD;
          -  Surgery (including open biopsy) within 4 weeks prior to the first planned dose of&#xD;
             bevacizumab&#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 line patency, in which case international normalized ratio (INR) must be&#xD;
             maintained below 1.5). Post operative prophylaxis with low molecular weight heparin sc&#xD;
             is allowed&#xD;
&#xD;
          -  Inadequate bone marrow function: absolute neutrophil count (ANC): &lt;1.5 x 109/l, or&#xD;
             platelet count &lt;100 x 109/l or haemoglobin &lt;9 g/dl. Patients may be transfused to&#xD;
             maintain haemoglobin values ≥9 g/dl&#xD;
&#xD;
          -  Inadequate coagulation parameters: activated partial thromboplastin time (APTT) &gt;1.5 x&#xD;
             upper limit of normal (ULN) or INR &gt;1.5&#xD;
&#xD;
          -  Inadequate liver function, defined as: serum (total) bilirubin &gt; ULN for the&#xD;
             institution AST/serum glutamic-oxaloacetic transaminase (SGOT) or ALT/ serum&#xD;
             glutamic-pyruvic transaminase (SGPT) &gt;2.5 x ULN&#xD;
&#xD;
          -  Inadequate renal function: serum creatinine &gt;1.5 mg/dL or &gt;132 micromol/L and urine&#xD;
             dipstick for proteinuria &gt; or = 2+ and &gt;1g of protein in their 24-hour urine&#xD;
             collection&#xD;
&#xD;
          -  History or evidence of brain metastases or spinal cord compression&#xD;
&#xD;
          -  Pregnant, breastfeeding women and women of child bearing potential, who do not agree&#xD;
             to use a medically acceptable method of contraception through the treatment period and&#xD;
             for 6 months after discontinuation of treatment&#xD;
&#xD;
          -  History or evidence of thrombotic or hemorrhagic disorders; including cerebrovascular&#xD;
             accident, stroke or transient ischemic attack or sub-arachnoid haemorrhage within 6&#xD;
             months prior to the first study treatment&#xD;
&#xD;
          -  Uncontrolled hypertension (sustained systolic &gt;150 mmHg and/or diastolic &gt;100 mmHg&#xD;
             despite antihypertensive therapy) or clinically significant (i.e. active)&#xD;
             cardiovascular disease, including: myocardial infarction or unstable angina within 6&#xD;
             months prior to the first study treatment, New York Heart Association grade II or&#xD;
             greater congestive heart failure, serious cardiac arrhythmia requiring medication&#xD;
&#xD;
          -  History of bowel obstruction, including subocclusive disease, related to the&#xD;
             underlying disease and history of abdominal fistula, gastrointestinal perforation or&#xD;
             intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination&#xD;
             or bowel involvement on CT scan or clinical symptoms of bowel obstruction&#xD;
&#xD;
          -  Non-healing wound, ulcer or bone fracture&#xD;
&#xD;
          -  hepatitis C virus (HCV) positivity&#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;
      </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>Nicoletta Colombo, Medical D</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Europeo di Oncologia di Milano</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliera Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO Fatebenefratelli e Oftalmico</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera S. Gerardo</name>
      <address>
        <city>Monza</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>Policlinico Universitario Agostino Gemelli di Roma</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mauriziano Hospital</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, D'Incalci M. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer. Br J Cancer. 2019 Oct;121(9):744-750. doi: 10.1038/s41416-019-0584-5. Epub 2019 Sep 20.</citation>
    <PMID>31537908</PMID>
  </results_reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 15, 2019</last_update_submitted>
  <last_update_submitted_qc>November 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer</keyword>
  <keyword>bevacizumab</keyword>
  <keyword>trabectedin</keyword>
  <keyword>carboplatin</keyword>
  <keyword>randomized trial</keyword>
  <keyword>phase II</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>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Trabectedin</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/NCT01735071
org study id: IRFMN-OVA-6152
nct id: NCT01735071
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study is aimed at assessing the efficacy and the safety of the combination of
      bevacizumab and trabectedin with or without carboplatin in adult women with epithelial
      ovarian cancer at first recurrence occurred 6-12 months after the end of the last (first or
      second) platinum-containing regimen. According to the Bryant and Day design the primary
      endpoints will be the proportion of progression-free patients at 6 months for the efficacy,
      and the proportion of patients with severe toxicity for the safety at the same time-point.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a multicentre, randomized, non-comparative phase II study aimed at assessing efficacy and safety of two regimens according to a Bryant and Day two-stage design
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival at 6 months (PFS-6)
time frame: from randomization up to 6 months
description: The PFS-6, defined as the percentage of patients who are alive and progression free at 6 months after the randomization.
measure: Proportion of patients with severe toxicity within 6 months from randomization.
time frame: from randomization up to 6 months
description: The following conditions will be considered as severe toxicity:
absolute neutrophil count (ANC) < 0.5x109/L lasting > 7 days and/or with fever
platelets < 25x109/L
any other grade 3-4 (evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 4.0) non-hematological toxicities except for reversible nausea/vomiting, diarrhea, hypersensitivity reactions, and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation reversible to grade 1 by day 28
any toxicity causing a delay of >14 days in the following cycle
measure: Progression Free Survival (PFS)
time frame: from randomization up to 30 months
description: Defined for each patient as the time from the date of randomization to the date of first progression, second primary malignancy or death for any cause, whichever comes first. Subjects not progressed or died at the time of the analysis will be censored at the last disease assessment date.
measure: Overall survival at 12 months (OS-12)
time frame: one year
description: Defined as the percentage of patients who are alive at 12 months after the randomization.
measure: Clinical Benefit (CB)
time frame: from randomization up to 30 months
description: clinical benefit, defined as the percentage of patients who are judged by the Investigators to have a complete response (CR), or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria, version 1.1 after 12 weeks from the date of randomization.
measure: Incidence of Adverse Events (AEs)
time frame: from randomization up to 30 months
description: Incidence of AEs, according to NCI-CTCAE, version 4.0
measure: Maximum toxicity grade
time frame: from randomization up to 30 months
description: Maximum toxicity grade experienced by each patient for each specific toxicity
measure: Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity
time frame: from randomization up to 30 months
description: Percentage of patients experiencing grade 3-4 toxicity for each specific toxicity during the study
measure: Patients with at least a Serious Adverse Drug Reaction (SADR)
time frame: from randomization up to 30 months
description: Patients with at least a SADR during the study
measure: Patients with at least a Suspect Unexpected Serious Adverse Reaction (SUSAR).
time frame: from randomization up to 30 months
description: Patients with at least a suspect unexpected serious adverse reaction during the study
measure: Percentage of patients with dose and/or time modifications
time frame: from randomization up to 30 months
description: Percentage of patients with dose and/or time modifications of the study drugs
measure: Percentage of premature withdrawals
time frame: from randomization up to 30 months
description: Percentage of premature withdrawals of the enrolled patients
measure: Patients with at least a Serious Adverse Event (SAE)
time frame: from randomization up to 30 months
description: Patients with at least a SAE during the study
measure: Nature of AEs
time frame: from randomization up to 30 months
description: Nature of AEs, according to NCI-CTCAE, version 4.0
measure: Severity of AEs
time frame: from randomization up to 30 months
description: Severity of AEs, according to NCI-CTCAE, version 4.0
measure: Seriousness of AEs
time frame: from randomization up to 30 months
description: Seriousness of AEs according to NCI-CTCAE, version 4.0
arm group label: bevacizumab and trabectedin
arm group type: Experimental
description: Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients
arm group label: bevacizumab, trabectedin and carboplatin
arm group type: Experimental
description: Arm B: cycle 1-6, bevacizumab given as 1 hour infusion will be followed by carboplatin area under curve 4 (AUC 4) and trabectedin 3 hour iv infusion.
Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.
Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.
From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days
intervention type: Drug
intervention name: bevacizumab and trabectedin
description: Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients
arm group label: bevacizumab and trabectedin
other name: Avastin
other name: Yondelis
intervention type: Drug
intervention name: bevacizumab, trabectedin and carboplatin
description: Arm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion.
Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.
Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.
From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days
arm group label: bevacizumab, trabectedin and carboplatin
other name: Avastin
other name: Yondelis
other name: Carboplatin
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicoletta Colombo, Medical D
role: Principal Investigator
affiliation: IRCCS Istituto Europeo di Oncologia di Milano
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
citation: Colombo N, Zaccarelli E, Baldoni A, Frezzini S, Scambia G, Palluzzi E, Tognon G, Lissoni AA, Rubino D, Ferrero A, Farina G, Negri E, Pesenti Gritti A, Galli F, Biagioli E, Rulli E, Poli D, Gerardi C, Torri V, Fossati R, D'Incalci M. Multicenter, randomised, open-label, non-comparative phase 2 trial on the efficacy and safety of the combination of bevacizumab and trabectedin with or without carboplatin in women with partially platinum-sensitive recurrent ovarian cancer. Br J Cancer. 2019 Oct;121(9):744-750. doi: 10.1038/s41416-019-0584-5. Epub 2019 Sep 20.
PMID: 31537908
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Bevacizumab
mesh term: Carboplatin
mesh term: Trabectedin