<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/NCT03809637</url>
  </required_header>
  <id_info>
    <org_study_id>4-2016-0389</org_study_id>
    <nct_id>NCT03809637</nct_id>
  </id_info>
  <brief_title>A Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma</brief_title>
  <official_title>Phase II Study of Pemetrexed Plus Cisplatin in Patients With Refractory Soft Tissue Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and&#xD;
      metastatic STS have a median overall survival of about 12 months. After the standard 1st line&#xD;
      chemotherapy with doxorubicin, the only a few treatment option is available. Recently,&#xD;
      pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent&#xD;
      lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated&#xD;
      and moderately effective. Based on the background, investigators planned to conduct the phase&#xD;
      II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue&#xD;
      sarcomas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>progression free rate</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>every 3 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Sarcoma</condition>
  <arm_group>
    <arm_group_label>pemetrexed+cisplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with metastatic sarcoma who underwent one chemotherapy regimens are treated with the combination of pemetrexed and cisplatin, and the treatment is repeated until the disease progression. pemetrexed 500 mg / m2 (day 1) and cisplatin 75 mg / m2 (day 1) are intravenously injected. 21 days is one cycle, and it is carried out by co-administration up to 6 cycles. After 7 cycles, intravenous injection of pemetrexed alone at intervals of 3 weeks until disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed, cisplatin</intervention_name>
    <description>Pemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered.</description>
    <arm_group_label>pemetrexed+cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed advanced bone and soft tissue sarcoma with prior chemotherapy&#xD;
             including anthracycline or ifosfamide&#xD;
&#xD;
          2. Measurable or evaluable disease (RECIST 1.1.)&#xD;
&#xD;
          3. Age ≥19 years&#xD;
&#xD;
          4. ECOG performance status of 0-2&#xD;
&#xD;
          5. Adequate laboratory findings&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1500 /µL&#xD;
&#xD;
               -  Platelet count ≥ 75,000/ µL&#xD;
&#xD;
               -  Serum creatinine &lt; 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               -  AST (SGOT) and ALT (SGPT) &lt; 3 x upper limit of normal (ULN)&#xD;
&#xD;
               -  Total bilirubin &lt;1.5 x upper limit of normal (ULN)&#xD;
&#xD;
          6. more than 3 months of expected survival&#xD;
&#xD;
          7. Provision of written informed consent prior to any study procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks&#xD;
             prior to entering the study'&#xD;
&#xD;
          2. Patient is pregnant or breastfeeding, or expecting to conceive or father children&#xD;
             within the projected duration of the study.&#xD;
&#xD;
          3. Resectable lung metastases&#xD;
&#xD;
          4. Uncontrolled or active CNS metastasis and/or carcinomatous meningitis&#xD;
&#xD;
          5. Other co-existing malignancies or malignancies diagnosed within the last 3 years with&#xD;
             the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.&#xD;
&#xD;
          6. Uncontrolled medical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 30, 2022</last_update_submitted>
  <last_update_submitted_qc>May 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yonsei University</investigator_affiliation>
    <investigator_full_name>Hyo Song Kim</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemetrexed</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03809637
org study id: 4-2016-0389
nct id: NCT03809637
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The yearly incidence of soft-tissue sarcomas(STS) in the USA is roughly 11,280 cases, and
      metastatic STS have a median overall survival of about 12 months. After the standard 1st line
      chemotherapy with doxorubicin, the only a few treatment option is available. Recently,
      pemetrexed, a novel multitargeted antifolate, has shown modest activity as a single agent
      lung cancer and mesothelioma. In patients with refractory STS, pemetrexed is well tolerated
      and moderately effective. Based on the background, investigators planned to conduct the phase
      II trial of pemetrexed in combination with cisplatin for metastatic/recurred soft-tissue
      sarcomas.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: progression free rate
time frame: 12 weeks
measure: adverse event
time frame: every 3 weeks
arm group label: pemetrexed+cisplatin
arm group type: Experimental
description: Patients with metastatic sarcoma who underwent one chemotherapy regimens are treated with the combination of pemetrexed and cisplatin, and the treatment is repeated until the disease progression. pemetrexed 500 mg / m2 (day 1) and cisplatin 75 mg / m2 (day 1) are intravenously injected. 21 days is one cycle, and it is carried out by co-administration up to 6 cycles. After 7 cycles, intravenous injection of pemetrexed alone at intervals of 3 weeks until disease progression.
intervention type: Drug
intervention name: Pemetrexed, cisplatin
description: Pemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered.
arm group label: pemetrexed+cisplatin
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Yonsei University
investigator full name: Hyo Song Kim
investigator title: professor
mesh term: Sarcoma
mesh term: Pemetrexed
sharing ipd: No