<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/NCT02226289</url>
  </required_header>
  <id_info>
    <org_study_id>BATTLE</org_study_id>
    <nct_id>NCT02226289</nct_id>
  </id_info>
  <brief_title>Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment</brief_title>
  <acronym>BATTLE</acronym>
  <official_title>Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sixth Affiliated Hospital, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor&#xD;
      (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and&#xD;
      second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with&#xD;
      cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm, phase II, open-labelled clinical trial to evaluate the safety and&#xD;
      efficacy of bevacizumab combined with cytotoxic agents in the treatment of patients with mCRC&#xD;
      progressing under all available cytotoxic chemotherapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Baseline and 6 weeks</time_frame>
    <description>Percentage of tumor regression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of treatment until the date of death of any cause, assessed up to 48 months</time_frame>
    <description>From date of treatment until the date of death of any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>From date of treatment until the date of disease progression, assessed up to 48 months</time_frame>
    <description>From date of treatment until the date of disease progression</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Neoplasm</condition>
  <condition>Colorectal Cancer</condition>
  <condition>Metastatic Neoplasm</condition>
  <arm_group>
    <arm_group_label>bevacizumab-containing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>bevacizumab with the latest received cytotoxic regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>bevacizumab with the latest received cytotoxic regimen</description>
    <arm_group_label>bevacizumab-containing</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent obtained.&#xD;
&#xD;
          -  Subjects must be able to understand and willing to sign a written informed consent.&#xD;
&#xD;
          -  Subjects &gt; 18 years of age&#xD;
&#xD;
          -  Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of&#xD;
             0 or 2.&#xD;
&#xD;
          -  Histological or cytological diagnosis of adenocarcinoma of the colon or rectum.&#xD;
&#xD;
          -  Subjects have unresectable metastatic lesions.&#xD;
&#xD;
          -  Subjects failed to respond to oxaliplatin, irinotecan and fluorouracil.&#xD;
&#xD;
          -  Subjects have at least one measurable lesion according to Response Evaluation Criteria&#xD;
             in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.&#xD;
&#xD;
          -  Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet&#xD;
             count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.&#xD;
&#xD;
          -  Total bilirubin ≤1.5 x the upper limit of normal (ULN).&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.&#xD;
&#xD;
          -  Amylase and lipase ≤ 1.5 x the ULN.&#xD;
&#xD;
          -  Serum creatinine ≤ 1.5 x the ULN.&#xD;
&#xD;
          -  Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous or concurrent cancer that is distinct in primary site or histology from&#xD;
             colorectal cancer within 5 years prior to this study.&#xD;
&#xD;
          -  Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2&#xD;
             weeks prior to randomization.&#xD;
&#xD;
          -  Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks&#xD;
             before start of study medication.&#xD;
&#xD;
          -  Uncontrolled hypertension. (systolic blood pressure &gt; 150 mmHg or diastolic pressure &gt;&#xD;
             90 mmHg despite optimal medical management).&#xD;
&#xD;
          -  Significant cardiovascular disease including unstable angina or myocardial infarction&#xD;
             within 6 months before initiating study treatment or a history of ventricular&#xD;
             arrhythmia&#xD;
&#xD;
          -  Arterial or venous thrombotic or embolic events such as cerebrovascular accident&#xD;
             (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism&#xD;
             within the 6 months before start of study medication.&#xD;
&#xD;
          -  Any evidence of active infection.&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  History of bleeding diathesis or coagulopathy.&#xD;
&#xD;
          -  History of interstitial pneumonitis or pulmonary fibrosis&#xD;
&#xD;
          -  Pregnancy or lactation at the time of study entry.&#xD;
&#xD;
          -  Any history of or currently known brain metastases.&#xD;
&#xD;
          -  Known dihydropyrimidine dehydrogenase (DPD) deficiency&#xD;
&#xD;
          -  Any illness or medical conditions that are unstable or could jeopardize the safety of&#xD;
             the subjects and his/her compliance in the study.&#xD;
&#xD;
          -  Subjects with known allergy to the study drugs or to any of its excipients.&#xD;
&#xD;
          -  Current or recent (within 4 weeks prior to starting study treatment) treatment of&#xD;
             another investigational drug or participation in another investigational study.&#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>Ping Lan, Ph D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jian Xiao, Ph D</last_name>
    <phone>86-20-38250745</phone>
    <email>xiaoj26@mail.sysu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Sixth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510655</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jian Xiao, Ph D</last_name>
      <phone>86-20-38250745</phone>
      <email>xiaoj26@mail.sysu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Ping Lan, Ph D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Jian Xiao</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>bevacizumab</keyword>
  <keyword>refractory</keyword>
  <keyword>colorectal cancer</keyword>
  <keyword>metastatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bevacizumab</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/NCT02226289
org study id: BATTLE
nct id: NCT02226289
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor
      (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and
      second-line treatment for metastatic colorectal cancer. The efficacy of bevacizumab with
      cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.
This is a single arm, phase II, open-labelled clinical trial to evaluate the safety and
      efficacy of bevacizumab combined with cytotoxic agents in the treatment of patients with mCRC
      progressing under all available cytotoxic chemotherapy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response rate
time frame: Baseline and 6 weeks
description: Percentage of tumor regression
measure: Overall survival
time frame: From date of treatment until the date of death of any cause, assessed up to 48 months
description: From date of treatment until the date of death of any cause
measure: Progression free survival
time frame: From date of treatment until the date of disease progression, assessed up to 48 months
description: From date of treatment until the date of disease progression
arm group label: bevacizumab-containing
arm group type: Experimental
description: bevacizumab with the latest received cytotoxic regimen
intervention type: Drug
intervention name: Bevacizumab
description: bevacizumab with the latest received cytotoxic regimen
arm group label: bevacizumab-containing
other name: Avastin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ping Lan, Ph D
role: Principal Investigator
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
last name: Jian Xiao, Ph D
phone: 86-20-38250745
email: xiaoj26@mail.sysu.edu.cn
facility: 
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
investigator full name: Jian Xiao
investigator title: Associate Professor
mesh term: Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Neoplasm Metastasis
mesh term: Bevacizumab
sharing ipd: No