<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/NCT01693445</url>
  </required_header>
  <id_info>
    <org_study_id>HMC-HO-GI-1203</org_study_id>
    <nct_id>NCT01693445</nct_id>
  </id_info>
  <brief_title>S-1, Oxaliplatin, and Irinotecan for Advanced Gastrointestinal Cancer</brief_title>
  <official_title>Dose Finding Study of S-1, Oxaliplatin, and Irinotecan Combination Chemotherapy for Patients With Inoperable Advanced or Metastatic Gastrointestinal Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jeil Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Handok Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hallym University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will attempt to determine the feasibility of combination of Oxaliplatin,&#xD;
      Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used,&#xD;
      and to preliminarily evaluate the antitumor activity in untreated patients with advanced&#xD;
      gastrointestinal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxaliplatin or irinotecan has shown a considerable anti-tumor activity, when used in&#xD;
      combination with 5-fluorouracil (5-FU) in patients with gastrointestinal (GI) cancer.&#xD;
      Oxaliplatin, irinotecan, and 5-FU have different mechanisms of actions and do not share the&#xD;
      toxicity profiles. Since they have a synergistic effect, many clinical trials have been&#xD;
      conducted recently to evaluate the efficacy of triplet combination consisting of oxaliplatin,&#xD;
      irinotecan, and 5-FU, and demonstrated that the triple combination regimen was effective and&#xD;
      resulted in survival benefits with favorable toxicity profiles.&#xD;
&#xD;
      S-1 and capecitabine are novel oral fluoropyrimidines and different phase III trials have&#xD;
      shown that these oral agents are at least as active and effective as 5-FU with a superior&#xD;
      safety profile.&#xD;
&#xD;
      Biweekly triple combination of S-1 with oxaliplatin and irinotecan (OIS) is an interesting&#xD;
      alternative to increase convenience and to simply the treatment delivery.&#xD;
&#xD;
      In the present study, we attempt to determine the feasibility of OIS combination, the maximum&#xD;
      tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate&#xD;
      the antitumor activity in untreated patients with advanced gastrointestinal cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 1</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>maximum tolerated dose</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>toxicity profiles</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall response rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>disease control rate</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Gastrointestinal Neoplasms</condition>
  <arm_group>
    <arm_group_label>OIS (Oxaliplatin, Irinotecan, S-1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose level 1 treatment will be delivered as a 2-week cycle as bellows;&#xD;
Oxaliplatin 85 mg/m²IV on day 1&#xD;
Irinotecan 120 mg/m² IV on day 1&#xD;
S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OIS (Oxaliplatin, Irinotecan, S-1)</intervention_name>
    <description>Dose level 1 treatment will be delivered as a 2-week cycle as bellows;&#xD;
Oxaliplatin 85 mg/m²IV on day 1&#xD;
Irinotecan 120 mg/m² IV on day 1&#xD;
S-1 60 mg/m2/day PO on day 1-7&#xD;
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.</description>
    <arm_group_label>OIS (Oxaliplatin, Irinotecan, S-1)</arm_group_label>
    <other_name>Kabioxaliplatin</other_name>
    <other_name>Campto</other_name>
    <other_name>TS-1</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven recurrent or metastatic adenocarcinoma of the gastrointestinal&#xD;
             tract&#xD;
&#xD;
          -  Minimum age of 18 years&#xD;
&#xD;
          -  ECOG Performance status 0-2&#xD;
&#xD;
          -  Life expectancy &gt;3 months&#xD;
&#xD;
          -  Presence of measurable or evaluable disease by RECIST&#xD;
&#xD;
          -  Prior adjuvant chemotherapy without S-1, oxaliplatin and irinotecan is allowed if more&#xD;
             than 4 weeks elapsed since completion of chemotherapy.&#xD;
&#xD;
          -  More than 4 weeks since completion of prior radiotherapy (measurable or evaluable&#xD;
             lesions should be outside the radiation field)&#xD;
&#xD;
          -  Adequate organ functions&#xD;
&#xD;
          -  Patients must sign an informed consent indicating that they are aware of the&#xD;
             investigational nature of the study in keeping with the policy of the hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated previously with S-1, oxaliplatin, or irinotecan as adjuvant&#xD;
             chemotherapy.&#xD;
&#xD;
          -  Patients with CNS metastases or carcinomatous leptomeningitis or neurologic disease.&#xD;
&#xD;
          -  Patients with active infection, severe heart disease, uncontrollable hypertension or&#xD;
             diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or&#xD;
             breast feeding&#xD;
&#xD;
          -  Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ&#xD;
             cancer of uterine cervix&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dae Young Zang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hallym University Medical Center</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>February 18, 2016</last_update_submitted>
  <last_update_submitted_qc>February 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastrointestinal neoplasms</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Irinotecan</keyword>
  <keyword>S-1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Irinotecan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT01693445
org study id: HMC-HO-GI-1203
nct id: NCT01693445
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study will attempt to determine the feasibility of combination of Oxaliplatin,
      Irinotecan, and S-1, the maximum tolerated dose and the recommended doses of the agents used,
      and to preliminarily evaluate the antitumor activity in untreated patients with advanced
      gastrointestinal cancer.
Oxaliplatin or irinotecan has shown a considerable anti-tumor activity, when used in
      combination with 5-fluorouracil (5-FU) in patients with gastrointestinal (GI) cancer.
      Oxaliplatin, irinotecan, and 5-FU have different mechanisms of actions and do not share the
      toxicity profiles. Since they have a synergistic effect, many clinical trials have been
      conducted recently to evaluate the efficacy of triplet combination consisting of oxaliplatin,
      irinotecan, and 5-FU, and demonstrated that the triple combination regimen was effective and
      resulted in survival benefits with favorable toxicity profiles.

      S-1 and capecitabine are novel oral fluoropyrimidines and different phase III trials have
      shown that these oral agents are at least as active and effective as 5-FU with a superior
      safety profile.

      Biweekly triple combination of S-1 with oxaliplatin and irinotecan (OIS) is an interesting
      alternative to increase convenience and to simply the treatment delivery.

      In the present study, we attempt to determine the feasibility of OIS combination, the maximum
      tolerated dose and the recommended doses of the agents used, and to preliminarily evaluate
      the antitumor activity in untreated patients with advanced gastrointestinal cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: maximum tolerated dose
time frame: 6 months
measure: toxicity profiles
time frame: 6 months
measure: overall response rate
time frame: 6 months
measure: progression free survival
time frame: 6 months
measure: overall survival
time frame: 6 months
measure: disease control rate
time frame: 6 months
arm group label: OIS (Oxaliplatin, Irinotecan, S-1)
arm group type: Experimental
description: Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
Oxaliplatin 85 mg/m²IV on day 1
Irinotecan 120 mg/m² IV on day 1
S-1 60 mg/m2/day PO on day 1-7 Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.
intervention type: Drug
intervention name: OIS (Oxaliplatin, Irinotecan, S-1)
description: Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
Oxaliplatin 85 mg/m²IV on day 1
Irinotecan 120 mg/m² IV on day 1
S-1 60 mg/m2/day PO on day 1-7
Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level.
arm group label: OIS (Oxaliplatin, Irinotecan, S-1)
other name: Kabioxaliplatin
other name: Campto
other name: TS-1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dae Young Zang, MD, PhD
role: Principal Investigator
affiliation: Hallym University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastrointestinal Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Oxaliplatin
mesh term: Irinotecan
sharing ipd: Undecided