<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/NCT02223884</url>
  </required_header>
  <id_info>
    <org_study_id>4-2011-0300</org_study_id>
    <nct_id>NCT02223884</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is the phase II, single-arm, single-center study assessing the efficacy of weekly&#xD;
      docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or&#xD;
      metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end&#xD;
      point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and&#xD;
      secondary end point includes disease control rate, progression free survival, overall&#xD;
      survival and safety.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Response Rate</measure>
    <time_frame>every 6 weeks, up to 4 year</time_frame>
    <description>Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>disease control rate</measure>
    <time_frame>every 6 weeks, up to 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>every 6 weeks, up to 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>every 6 weeks, up to 4 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>every 6 weeks, up to 4 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Malignant Melanoma</condition>
  <arm_group>
    <arm_group_label>weekly docetaxel and carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>docetaxel 35mg/m2</intervention_name>
    <description>D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks</description>
    <arm_group_label>weekly docetaxel and carboplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin AUC3</intervention_name>
    <description>D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks</description>
    <arm_group_label>weekly docetaxel and carboplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically proven malignant melanoma (recurred or metastatic) that&#xD;
             had progressed during or after receiving at least one cycle of a regimen containing&#xD;
             dacarbazine or temozolomide in the advanced setting&#xD;
&#xD;
          -  Measurable disease (RECIST)&#xD;
&#xD;
          -  ECOG performance 0-2&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Total bilirubin &lt;1.5N ; ASAT and ALAT &lt;2.5N&#xD;
&#xD;
          -  Serum Creatinin &lt; 1.5N&#xD;
&#xD;
          -  ANC ≥ 1,500/mm³ (G-CSF allowed)&#xD;
&#xD;
          -  Platelets ≥ 100,000/mm³&#xD;
&#xD;
          -  Hb ≥ 9.0 g/dL&#xD;
&#xD;
          -  Life expectancy of at least 12 weeks&#xD;
&#xD;
          -  Signed Written Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic brain metastasis&#xD;
&#xD;
          -  Previous history of treatment with taxane or platinum agent containing chemotherapy&#xD;
&#xD;
          -  Previous major surgery within 2 weeks before the start of the trial, or a failure to&#xD;
             recover from the surgery&#xD;
&#xD;
          -  Previous history of other malignancies within 5 years except for cured skin basal cell&#xD;
             carcinoma or cured in-situ cervix cancer&#xD;
&#xD;
          -  Other severe medical conditions (infection, uncontrolled hypertension, heart failure,&#xD;
             MI history within 6 months)&#xD;
&#xD;
          -  Sensitivity to platinum agents or docetaxel&#xD;
&#xD;
          -  Uncontrolled seizure&#xD;
&#xD;
          -  Women pregnant or nursing&#xD;
&#xD;
          -  Alcohol or drug abuser&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>August 27, 2014</last_update_submitted>
  <last_update_submitted_qc>August 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Malignant melanoma, second-line treatment, docetaxel, carboplatin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Docetaxel</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/NCT02223884
org study id: 4-2011-0300
nct id: NCT02223884
lead sponsor: 
has dmc: No
This is the phase II, single-arm, single-center study assessing the efficacy of weekly
      docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or
      metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end
      point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and
      secondary end point includes disease control rate, progression free survival, overall
      survival and safety.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rate
time frame: every 6 weeks, up to 4 year
description: Response rate evaluation based on RECIST 1.1 confirmed by CT or MRI
measure: disease control rate
time frame: every 6 weeks, up to 4 year
measure: progression free survival
time frame: every 6 weeks, up to 4 year
measure: overall survival
time frame: every 6 weeks, up to 4 year
measure: adverse events
time frame: every 6 weeks, up to 4 year
arm group label: weekly docetaxel and carboplatin
arm group type: Experimental
intervention type: Drug
intervention name: docetaxel 35mg/m2
description: D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
arm group label: weekly docetaxel and carboplatin
intervention type: Drug
intervention name: Carboplatin AUC3
description: D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
arm group label: weekly docetaxel and carboplatin
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Carboplatin
mesh term: Docetaxel