<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/NCT01667211</url>
  </required_header>
  <id_info>
    <org_study_id>CH-GYN-001</org_study_id>
    <secondary_id>11-92/527</secondary_id>
    <nct_id>NCT01667211</nct_id>
  </id_info>
  <brief_title>Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Cervical Cancer</brief_title>
  <acronym>CSAPPPCC</acronym>
  <official_title>A Single Center, Non-randomized, Open Phase II Clinical Study of Albumin-bound Paclitaxel Plus Nedaplatin in Patients With Advanced, Recurrent Metastatic Cervical Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis&#xD;
      cervical cancer, to evaluate the efficacy and toxic reaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of&#xD;
      paclitaxel designed to avoid problems associated with solvents used in Taxol. And&#xD;
      albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,&#xD;
      and with greater concentration in tumor tissue compared with normal tissues. This is a single&#xD;
      center, non-randomized, open-label Phase II clinical study to investigate the efficacy and&#xD;
      tolerability of albumin-bound paclitaxel plus nedaplatin in patients with advanced, recurrent&#xD;
      metastatic cervical cancer. About 30 patients will receive 175-200 mg/m2 albumin-bound&#xD;
      paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3 weeks. At least 2 cycles&#xD;
      will be completed for each patient, for whom responded to the treatment, 4-6 cycles will be&#xD;
      completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2011</start_date>
  <completion_date type="Anticipated">December 2016</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>response rate</measure>
    <time_frame>one year</time_frame>
    <description>Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to progression (TTP)</measure>
    <time_frame>2 years</time_frame>
    <description>Measure of time from study treatment to disease progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-year progression-free survival (PFS)</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of patients who have PFS two years after receiving study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety and tolerability</measure>
    <time_frame>2 years</time_frame>
    <description>Percentage of patients who experience an adverse event during this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>5 years</time_frame>
    <description>Measure of time from study treatment to patient's death or lost to follow-up.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Uterine Cervical Cancer</condition>
  <arm_group>
    <arm_group_label>albumin-bound paclitaxel plus nedaplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>albumin-bound paclitaxel plus nedaplatin: Intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>albumin-bound paclitaxel plus nedaplatin</intervention_name>
    <description>intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.</description>
    <arm_group_label>albumin-bound paclitaxel plus nedaplatin</arm_group_label>
    <other_name>Abraxane (albumin-bound paclitaxel)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cervical cancer, advanced or recurrent metastasis&#xD;
&#xD;
          -  Measurable and assessible tumor lesions&#xD;
&#xD;
          -  Used ordinary paclitaxel or platinum drugs, more than 28 days&#xD;
&#xD;
          -  Aged 18-70&#xD;
&#xD;
          -  KPS score&gt; 60 points, expected to survive more than 3 months&#xD;
&#xD;
          -  Normal bone marrow function&#xD;
&#xD;
          -  The function of liver and kidney had no obvious damage&#xD;
&#xD;
          -  Normal function of vital organs&#xD;
&#xD;
          -  No brain metastases&#xD;
&#xD;
          -  Patients or their agents to sign informed consent&#xD;
&#xD;
          -  Compliance, and can be followed up regularly&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Brain metastases&#xD;
&#xD;
          -  Serious complications&#xD;
&#xD;
          -  Acute inflammatory response&#xD;
&#xD;
          -  Combined with other tumor&#xD;
&#xD;
          -  Pregnancy or breast-feeding women&#xD;
&#xD;
          -  Vertebral metastasis with nerve compression symptoms&#xD;
&#xD;
          -  Large volume of pleural effusion, pericardial effusion&#xD;
&#xD;
          -  Other malignancy within five years&#xD;
&#xD;
          -  Drug allergy&#xD;
&#xD;
          -  Other chemotherapy contraindications&#xD;
&#xD;
          -  The possibility of pregnancy, and not willing to contraception&#xD;
&#xD;
          -  No measurement of lesion&#xD;
&#xD;
          -  Mental illness which is difficult to control&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rong Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rong Zhang</last_name>
    <phone>008613911982343</phone>
    <email>super0078888@sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chinese Academy of Medical Sciences, Cancer Hospital, Gynecologic Oncology</name>
      <address>
        <city>Beijing</city>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rong Zhang</last_name>
      <phone>008613911982343</phone>
      <email>super0078888@sina.com</email>
    </contact>
    <investigator>
      <last_name>Rong Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 21, 2012</last_update_submitted>
  <last_update_submitted_qc>August 21, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Zhang rong</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>Advanced uterine cervical cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical 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>
    <mesh_term>Nedaplatin</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/NCT01667211
org study id: CH-GYN-001
secondary id: 11-92/527
nct id: NCT01667211
lead sponsor: 
has dmc: No
Using albumin-bound paclitaxel and nedaplatin in the advanced or recurrent metastasis
      cervical cancer, to evaluate the efficacy and toxic reaction.
Albumin-bound paclitaxel is a novel, solvent-free, albumin-bound nanoparticle form of
      paclitaxel designed to avoid problems associated with solvents used in Taxol. And
      albumin-bound paclitaxel was characterized with high tolerated doses with greater efficacy,
      and with greater concentration in tumor tissue compared with normal tissues. This is a single
      center, non-randomized, open-label Phase II clinical study to investigate the efficacy and
      tolerability of albumin-bound paclitaxel plus nedaplatin in patients with advanced, recurrent
      metastatic cervical cancer. About 30 patients will receive 175-200 mg/m2 albumin-bound
      paclitaxel, d 1 combined with 80- 100 mg/m2 nedaplatin, d 2, every 3 weeks. At least 2 cycles
      will be completed for each patient, for whom responded to the treatment, 4-6 cycles will be
      completed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response rate
time frame: one year
description: Percentage of patients who achieve partial response (PR)/ complete response (CR) based on RECIST
measure: Time to progression (TTP)
time frame: 2 years
description: Measure of time from study treatment to disease progression
measure: 2-year progression-free survival (PFS)
time frame: 2 years
description: Percentage of patients who have PFS two years after receiving study treatment.
measure: safety and tolerability
time frame: 2 years
description: Percentage of patients who experience an adverse event during this study.
measure: Overall survival (OS)
time frame: 5 years
description: Measure of time from study treatment to patient's death or lost to follow-up.
arm group label: albumin-bound paclitaxel plus nedaplatin
arm group type: Experimental
description: albumin-bound paclitaxel plus nedaplatin: Intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.
intervention type: Drug
intervention name: albumin-bound paclitaxel plus nedaplatin
description: intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.
arm group label: albumin-bound paclitaxel plus nedaplatin
other name: Abraxane (albumin-bound paclitaxel)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rong Zhang
role: Principal Investigator
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
last name: Rong Zhang
phone: 008613911982343
email: super0078888@sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Zhang rong
investigator title: Chief Physician
mesh term: Uterine Cervical Neoplasms
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Nedaplatin