<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/NCT01705158</url>
  </required_header>
  <id_info>
    <org_study_id>MYCA (GINECO-OV220)</org_study_id>
    <secondary_id>2012-001999-10</secondary_id>
    <nct_id>NCT01705158</nct_id>
  </id_info>
  <brief_title>Myocet ® - Carboplatine in Ovarian Cancer in Relapse, Sensitive to the Platinum</brief_title>
  <acronym>MYCA</acronym>
  <official_title>Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ARCAGY/ GINECO GROUP</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ARCAGY/ GINECO GROUP</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the efficacy and the safety of the association of&#xD;
      carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive&#xD;
      to platin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In front of a shortage of Caelyx, the implementation of an alternative treatment must be&#xD;
      considered to treat patients with ovarian cancer in relapse, sensitive to platin: associate&#xD;
      the carboplatin with another drug of the family of the doxorubicin: liposomal doxorubicin&#xD;
      (Myocet®).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1/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>Determine the control disease rate in 1 year</measure>
    <time_frame>12 months</time_frame>
    <description>To determine the proportion of not progressive patients in 1 year (rate of control of the disease or the rate of not progress in 12 months)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To estimate the rate of objective answer (CR/PR)</measure>
    <time_frame>2,5 years</time_frame>
    <description>To estimate the survival without progress (PFS)&#xD;
To estimate the overal survival (OS)&#xD;
To estimate the profile of toxicity of the association.&#xD;
Quality of life.&#xD;
Validation of the clearance of CA-125 as predictive marker of the efficiency of the treatment and as factor forecast of the survival.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>carboplatin and liposomal doxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>carboplatin and liposomal doxorubicin in ovarian cancer in realapse</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>carboplatin and liposomal doxorubicin</intervention_name>
    <description>Carboplatin AUC5 and liposomal doxorubicin 40 or 50 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.</description>
    <arm_group_label>carboplatin and liposomal doxorubicin</arm_group_label>
    <other_name>carboplatin</other_name>
    <other_name>liposomal doxorubicin, Myocet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First or second relapse of a carcinoma of the ovary, the fallopian tubes or the&#xD;
             peritoneal tissue histological proved.&#xD;
&#xD;
          -  Interval without progress &gt; 6 months after the last administration of a salt of&#xD;
             platinum(deck).&#xD;
&#xD;
          -  Measurable Disease (according to the criteria RECIST 1.1) or an assessable disease&#xD;
             according to CA-125 (according to the criteria of the GCIG).&#xD;
&#xD;
          -  Satisfactory biological Balance sheet(Assessment), according to the following&#xD;
             criteria:&#xD;
&#xD;
               -  Neutrophiles &gt; 1,5x 109/L, Plaques &gt; 100 x 109/L, Haemoglobin &gt; 9,0 g/dL.&#xD;
&#xD;
               -  Bilirubine &lt; 1.5 x LSN (Normal Superior Limit), transaminases and alkaline&#xD;
                  phosphatase &lt; 2. 5 x LSN.&#xD;
&#xD;
               -  Creatinin clearance &gt; 50 mL/min calculated according to the formula of&#xD;
                  Cockroft-Gault or MDRD.&#xD;
&#xD;
          -  Performance status &lt; 2.&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks.&#xD;
&#xD;
          -  Age &gt; 18 years.&#xD;
&#xD;
          -  Capacity to follow the protocol.&#xD;
&#xD;
          -  Consent signed before any procedure of inclusion.&#xD;
&#xD;
          -  Membership in a national insurance scheme.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Tumor of mild histology or borderline, or malignant not epithelial tumor of the ovary,&#xD;
             the fallopian tubes or the peritoneal tissue(eg. tumor of germ cells, tumor of the&#xD;
             sexual cords and the stroma).&#xD;
&#xD;
          -  History of abdominal or pelvic radiotherapy.&#xD;
&#xD;
          -  Patient having received more than 2 lines of chemotherapy.&#xD;
&#xD;
          -  Patient in 3rd relapse or more.&#xD;
&#xD;
          -  History of another malignant tumor during the last 5 years, with the exception of a&#xD;
             carcinoma in situ by the neck of the womb or by a squamous-cell carcinoma of the skin&#xD;
             treated in a adequate way or any solid tumor considered in forgiveness completes&#xD;
             without relapse for at least 5 years.&#xD;
&#xD;
          -  Patients having a stubborn illness in the platinum, (eg. progress during the last&#xD;
             chemotherapy or in 6 months following the last administration of platinum).&#xD;
&#xD;
          -  Occlusive or sub-occlusive disease or presence of symptomatic intellectual metastases.&#xD;
&#xD;
          -  Heart disorder dissuading the use of an anthracycline.&#xD;
&#xD;
          -  Left venticular ejection fraction (LVEF) defined by MUGA/ECHO &lt; 50%.&#xD;
&#xD;
          -  Wait presenting a severe infection.&#xD;
&#xD;
          -  Woman old enough to procreate not using adequate contraceptive method.&#xD;
&#xD;
          -  Concomitant disease not allowing a surgery and/or a chemotherapy.&#xD;
&#xD;
          -  Pathology severe or concomitant not compatible with the taking of the study treatment&#xD;
             or the participation of the patient in the study.&#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>Gilles FREYER, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civiles de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de Radiothérapie et d'Oncologie</name>
      <address>
        <city>Agen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Paul Papin</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital jean Minjoz</name>
      <address>
        <city>Besancon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Tivoli</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Morvan - Centre Hospitalier Universitaire</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cholet</name>
      <address>
        <city>Cholet</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont-ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental Les Oudairies</name>
      <address>
        <city>La Roche Sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital André Mignot</name>
      <address>
        <city>Le Chesnay</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Mans</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dupuytren</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Scorff</name>
      <address>
        <city>Lorient</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon bérard</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital privé Jean Mermoz</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmettes</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de Mont-de-Marsan</name>
      <address>
        <city>Mont-de-Marsan</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICM Val d'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Azuréen de Cancérologie</name>
      <address>
        <city>Mougins</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Catherine de Sienne</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique KENVAL - Site de Valdegour</name>
      <address>
        <city>Nimes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régional d'Orléans</name>
      <address>
        <city>Orleans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Saint-Joseph</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital des Diaconesses</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Général de Pau</name>
      <address>
        <city>PAU Universite</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Francheville</name>
      <address>
        <city>Perigueux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-benite</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Région d'Annecy</name>
      <address>
        <city>Pringy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre intercommunal de Quimper</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jean Godinot</name>
      <address>
        <city>Reims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier privé de Saint Grégoire</name>
      <address>
        <city>Saint Gregoire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Armoricaine</name>
      <address>
        <city>Saint-Brieuc</city>
        <zip>22015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste de l'Estuaire</name>
      <address>
        <city>Saint-nazaire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO René Gauducheau</name>
      <address>
        <city>St Herblain</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut cancérologuie de la loire</name>
      <address>
        <city>St Priest en Jarez</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Radiothérapie - Clinique Sainte-Anne</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier General de Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre d'oncologie Saint-Yves</name>
      <address>
        <city>Vannes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bretagne Atlantique</name>
      <address>
        <city>Vannes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>October 1, 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>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ovarian cancer in relapse</keyword>
  <keyword>sensitive in platin</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>
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</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/NCT01705158
org study id: MYCA (GINECO-OV220)
secondary id: 2012-001999-10
nct id: NCT01705158
lead sponsor: 
has dmc: No
The purpose of this study is to determine the efficacy and the safety of the association of
      carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive
      to platin.
In front of a shortage of Caelyx, the implementation of an alternative treatment must be
      considered to treat patients with ovarian cancer in relapse, sensitive to platin: associate
      the carboplatin with another drug of the family of the doxorubicin: liposomal doxorubicin
      (Myocet®).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the control disease rate in 1 year
time frame: 12 months
description: To determine the proportion of not progressive patients in 1 year (rate of control of the disease or the rate of not progress in 12 months)
measure: To estimate the rate of objective answer (CR/PR)
time frame: 2,5 years
description: To estimate the survival without progress (PFS)
To estimate the overal survival (OS)
To estimate the profile of toxicity of the association.
Quality of life.
Validation of the clearance of CA-125 as predictive marker of the efficiency of the treatment and as factor forecast of the survival.
arm group label: carboplatin and liposomal doxorubicin
arm group type: Experimental
description: carboplatin and liposomal doxorubicin in ovarian cancer in realapse
intervention type: Drug
intervention name: carboplatin and liposomal doxorubicin
description: Carboplatin AUC5 and liposomal doxorubicin 40 or 50 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.
arm group label: carboplatin and liposomal doxorubicin
other name: carboplatin
other name: liposomal doxorubicin, Myocet
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles FREYER, Dr
role: Principal Investigator
affiliation: Hospices Civiles de Lyon
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country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Hypersensitivity
mesh term: Recurrence
mesh term: Carboplatin
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin