<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/NCT02229045</url>
  </required_header>
  <id_info>
    <org_study_id>ABI-FU</org_study_id>
    <nct_id>NCT02229045</nct_id>
  </id_info>
  <brief_title>Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer</brief_title>
  <official_title>Phase II Study of Albumin Bound Paclitaxel With 5-FU and CF as Second Line in Taxanes Naive Advanced Gastric Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness and safety of albumin bound&#xD;
      paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients&#xD;
      with advanced gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2010</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 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>PFS(Progression-free survival )</measure>
    <time_frame>80% PFS events,, an expected average of 10 months</time_frame>
    <description>The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS (Overall survival )</measure>
    <time_frame>OS follow-up period: 18 months or 80% OS events, whichever occurs first</time_frame>
    <description>Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ORR (Overall tumor response)</measure>
    <time_frame>80% PFS events, an expected average of 10 months</time_frame>
    <description>Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">37</enrollment>
  <condition>Gastric Caner</condition>
  <arm_group>
    <arm_group_label>Albumin Bound Paclitaxel With 5-FU/CF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albumin Bound Paclitaxel</intervention_name>
    <description>Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.</description>
    <arm_group_label>Albumin Bound Paclitaxel With 5-FU/CF</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5-FU</intervention_name>
    <description>5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.</description>
    <arm_group_label>Albumin Bound Paclitaxel With 5-FU/CF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed adenocarcinoma of the stomach with inoperable locally&#xD;
             advanced or recurrent and/or metastatic disease.&#xD;
&#xD;
          -  Male or female.&#xD;
&#xD;
          -  Age 18 -75.&#xD;
&#xD;
          -  Previous one line of non-taxane chemotherapy for advanced/metastatic disease.&#xD;
&#xD;
          -  Measurable disease, according to the Response Evaluation Criteria in Solid&#xD;
             Tumours(RECIST)&#xD;
&#xD;
          -  ECOG Performance status 0, 1 or 2&#xD;
&#xD;
          -  Haematological, Biochemical and Organ Function: Neutrophil count &gt;2.0 × 10 9/L,&#xD;
             platelet count &gt; 100 ×10 9/L. Serum bilirubin&lt; 1.5 × upper limit of normal (ULN); or,&#xD;
             AST or ALT &lt; 2.5 × ULN (or &lt; 5 × ULN in patients with liver metastases); or, alkaline&#xD;
             phosphatase&lt; 2.5 × ULN (or &gt; 5 × ULN in patients with liver metastases,Creatinine&#xD;
             clearance &gt; 60 mL/min.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No prior chemotherapy for gastric cancer.&#xD;
&#xD;
          -  Received any investigational drug treatment within 30 days of start of study&#xD;
             treatment.&#xD;
&#xD;
          -  Patients with active gastrointestinal bleeding.&#xD;
&#xD;
          -  Neurological toxicity ≥ grade 2 NCI-CTCAE.&#xD;
&#xD;
          -  Other malignancy within the last 5 years, except for carcinoma in situ of the cervix,&#xD;
             or basal cell carcinoma.&#xD;
&#xD;
          -  History or clinical evidence of brain metastases.&#xD;
&#xD;
          -  Serious uncontrolled systemic intercurrent illness, e.g. infections or poorly&#xD;
             controlled diabetes.&#xD;
&#xD;
          -  Pregnancy women.&#xD;
&#xD;
          -  Subjects with reproductive potential not willing to use an effective method of&#xD;
             contraception.&#xD;
&#xD;
          -  Patients with known active infection with HIV.&#xD;
&#xD;
          -  Known hypersensitivity to any of the study drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruihua Xu, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruihua Xu, PhD,MD</last_name>
    <phone>862087343228</phone>
    <email>xurh@sysucc.org.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dongsheng Zhang, PhD,MD</last_name>
    <phone>862087343795</phone>
    <email>zhangdsh@sysucc.org.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruihua Xu, Ph D,MD</last_name>
      <phone>862087343228</phone>
    </contact>
    <contact_backup>
      <last_name>Dongsheng Zhang, Ph D,MD</last_name>
      <phone>862087343795</phone>
      <email>zhangdsh@sysucc.org.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>March 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Ruihua Xu</investigator_full_name>
    <investigator_title>Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center</investigator_title>
  </responsible_party>
  <keyword>gastric caner</keyword>
  <keyword>Albumin Bound Paclitaxel</keyword>
  <keyword>5-FU/CF</keyword>
  <keyword>taxanes naive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</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/NCT02229045
org study id: ABI-FU
nct id: NCT02229045
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effectiveness and safety of albumin bound
      paclitaxel plus 5-FU and as second-line therapy in the treatment of taxanes naive patients
      with advanced gastric cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS(Progression-free survival )
time frame: 80% PFS events,, an expected average of 10 months
description: The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death
measure: OS (Overall survival )
time frame: OS follow-up period: 18 months or 80% OS events, whichever occurs first
description: Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
measure: ORR (Overall tumor response)
time frame: 80% PFS events, an expected average of 10 months
description: Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
arm group label: Albumin Bound Paclitaxel With 5-FU/CF
arm group type: Experimental
description: Albumin Bound Paclitaxel 150 mg/m2 (on day 1),5FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
intervention type: Drug
intervention name: Albumin Bound Paclitaxel
description: Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
arm group label: Albumin Bound Paclitaxel With 5-FU/CF
other name: Abraxane
intervention type: Drug
intervention name: 5-FU
description: 5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
arm group label: Albumin Bound Paclitaxel With 5-FU/CF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ruihua Xu, PhD,MD
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Ruihua Xu, PhD,MD
phone: 862087343228
email: xurh@sysucc.org.cn
last name: Dongsheng Zhang, PhD,MD
phone: 862087343795
email: zhangdsh@sysucc.org.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Ruihua Xu
investigator title: Professor of Medical Oncology,Vice-president of Sun Yat-sen University Cancer Center
mesh term: Stomach Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel