<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/NCT03818282</url>
  </required_header>
  <id_info>
    <org_study_id>2019-GYN/OC-01</org_study_id>
    <nct_id>NCT03818282</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) for First-line Chemotherapy of Ovarian Cancer</brief_title>
  <acronym>OC-01</acronym>
  <official_title>Efficacy and Safety of Paclitaxel for Injection (Albumin-bound) in Combination With Carboplatin for First-line Chemotherapy of Ovarian Cancer: A Multicenter, Open-label, Single-arm Phase 2 Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</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>
      Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound)&#xD;
      in combination with carboplatin for first-line chemotherapy of ovarian cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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 Survival</measure>
    <time_frame>2 year</time_frame>
    <description>PFS</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">77</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Paclitaxel for injection (albumin-bound)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel for injection (albumin-bound)</intervention_name>
    <description>Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.</description>
    <arm_group_label>Paclitaxel for injection (albumin-bound)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 to 75 years;&#xD;
&#xD;
          -  Histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary&#xD;
             peritoneal cancer;&#xD;
&#xD;
          -  Patients with stage IC-IV according to the International Federation of Obstetrics and&#xD;
             Gynecology (FIGO) and who underwent an ideal tumor reduction procedure within 6 weeks&#xD;
             prior to enrollment;&#xD;
&#xD;
          -  Lesion is measurable according to RECIST 1.1 criteria or patient's CA125 is evaluable&#xD;
             according to GCIG criteria;&#xD;
&#xD;
          -  ECOG performance status of 0-2;&#xD;
&#xD;
          -  Expected survival ≥ 3 months;&#xD;
&#xD;
          -  Bone marrow function: Neutrophils ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90&#xD;
             g/L;&#xD;
&#xD;
          -  Hepatic and renal function: Serum creatinine ≤ 1.5×ULN; AST and ALT ≤ 1.5×ULN or ≤&#xD;
             5×ULN in the presence of hepatic metastasis; Total bilirubin ≤ 1.5×ULN, or ≤ 2.5×ULN&#xD;
             in patients with Gilbert's syndrome;&#xD;
&#xD;
          -  Must agree to use effective contraception during the trial; Women of childbearing&#xD;
             potential must have a negative serum or urine pregnancy test; Non-lactating patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ovarian low-grade malignant tumor patients;&#xD;
&#xD;
          -  Patients who have received abdominal or pelvic radiotherapy;&#xD;
&#xD;
          -  Patients with central nervous system disease or brain metastases;&#xD;
&#xD;
          -  Other malignancies have occurred within the last 5 years, except for cervical&#xD;
             carcinoma in situ, non-melanoma skin cancers that have been cured;&#xD;
&#xD;
          -  Prior Grade ≥ 2 sensory or motor neuropathy;&#xD;
&#xD;
          -  Uncontrolled serious medical conditions that, in the opinion of the investigator,&#xD;
             would affect the ability of the subject to receive the study regimen, such as&#xD;
             concomitant serious medical conditions, including severe heart disease,&#xD;
             cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension,&#xD;
             uncontrolled infection, active peptic ulcer, etc.;&#xD;
&#xD;
          -  Known to be hypersensitive, highly sensitive, or intolerant to study-related&#xD;
             medications or their excipients;&#xD;
&#xD;
          -  Receive other study drug chemotherapy within 30 days of the first dose of&#xD;
             chemotherapy;&#xD;
&#xD;
          -  Patients not suitable for participation in this study judged by investigator.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ding Ma, M.D.</last_name>
    <phone>02783663351</phone>
    <email>dma@tjh.tjmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Danhui Weng, M.D.</last_name>
    <phone>02783663351</phone>
    <email>weng.dh@gmail.com</email>
  </overall_contact_backup>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Ding Ma</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03818282
org study id: 2019-GYN/OC-01
nct id: NCT03818282
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound)
      in combination with carboplatin for first-line chemotherapy of ovarian cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free Survival
time frame: 2 year
description: PFS
arm group label: Paclitaxel for injection (albumin-bound)
arm group type: Experimental
intervention type: Drug
intervention name: Paclitaxel for injection (albumin-bound)
description: Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.
arm group label: Paclitaxel for injection (albumin-bound)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ding Ma, M.D.
phone: 02783663351
email: dma@tjh.tjmu.edu.cn
last name: Danhui Weng, M.D.
phone: 02783663351
email: weng.dh@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Ding Ma
investigator title: Director
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Paclitaxel