<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/NCT02262897</url>
  </required_header>
  <id_info>
    <org_study_id>FK1401</org_study_id>
    <nct_id>NCT02262897</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer</brief_title>
  <official_title>Single Arm Phase II Clinical Trial to Investigate the Efficacy and Safety of Nab-paclitaxel as a Single Agent in the Small Cell Lung Cancer Patients With Extensive Disease and Failed to First Line/ Second Line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tongji University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tongji University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis,&#xD;
      even though the first line chemotherapy showing about 70% response rate. Most of the patients&#xD;
      will relapse with in 6 months after the chemotherapy and the following therapy such as second&#xD;
      line chemotherapy have a very limited efficacy to these patients. Currently, there is no&#xD;
      standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).&#xD;
&#xD;
      As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases&#xD;
      report in the patients with SCLC, the aim of this clinical trial is to investigate the&#xD;
      efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive&#xD;
      disease and failed to first line/ second line chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary end point: Objective Response Rate(ORR)&#xD;
&#xD;
      Secondary end point:&#xD;
&#xD;
      Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common&#xD;
      Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2013</start_date>
  <completion_date type="Anticipated">May 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2015</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>Objective Response Rate</measure>
    <time_frame>tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months</time_frame>
    <description>To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>24 months</time_frame>
    <description>PFS is evaluated in the 24 months since the treatment began</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>24 months</time_frame>
    <description>evaluated in the 24th month since the treatment began</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>24 months</time_frame>
    <description>evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality Of Life</measure>
    <time_frame>24 months</time_frame>
    <description>evaluated in the 24th month since the treatment began</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Nab-paclitaxel single agent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel</intervention_name>
    <description>Nab-paclitaxel weekly chemotherapy 130mg/m2, d1,8,15,every 4 week or Nab-paclitaxel chemotherapy once a time with a dose of 230 mg/m2 every 3 weeks</description>
    <arm_group_label>Nab-paclitaxel single agent</arm_group_label>
    <other_name>Albumin-bound paclitaxel， Abraxane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Obtain of informed consent.&#xD;
&#xD;
          2. Male or female aged 18 years and over.&#xD;
&#xD;
          3. Histologically or cytologically confirmed small cell lung carcinoma.&#xD;
&#xD;
          4. Extensive disease before receive nab-paclitaxel.&#xD;
&#xD;
          5. Failed to previous chemotherapy, but the previous paclitaxel chemotherapy is not&#xD;
             allowed.&#xD;
&#xD;
          6. World Health Organization (WHO) performance status (PS) of 0 to 2.&#xD;
&#xD;
          7. Females of child-bearing potential must have negative serum pregnancy test. Sexually&#xD;
             active males and females (of childbearing potential) willing to practice contraception&#xD;
             during the study.&#xD;
&#xD;
          8. Heart index values is in the range, as defined below, within two weeks of&#xD;
             randomization:&#xD;
&#xD;
               -  Absolute neutrophils count(ANC)≥2.0×109/L&#xD;
&#xD;
               -  Platelets≥100×109/L&#xD;
&#xD;
               -  Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)&#xD;
                  ≤2.5×ULN(≤5×ULN if liver metastases)&#xD;
&#xD;
               -  Creatinine clearance≥60ml/min&#xD;
&#xD;
          9. Measurable disease according to Response Evaluation Criteria in Solid Tumors(RECIST)&#xD;
             criteria with at least one measurable lesion not previously irradiated.&#xD;
&#xD;
         10. Life expectancy ≥12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. As judged by the investigator, any evidence of severe or uncontrolled systemic disease&#xD;
             (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).&#xD;
&#xD;
          2. Newly diagnosed Central Nervous System (CNS) metastases that have not yet been&#xD;
             definitively treated with surgery and/or radiation.&#xD;
&#xD;
          3. Known severe hypersensitivity to nab-paclitaxel or any of the excipients of these&#xD;
             products.Known severe hypersensitivity to pre-medications required for treatment with&#xD;
             nab-paclitaxel doublet chemotherapy.&#xD;
&#xD;
          4. Prior treatment with paclitaxel.&#xD;
&#xD;
          5. Pregnant or lactating woman.&#xD;
&#xD;
          6. Other co-existing malignancies or malignancies diagnosed within the last 5 years with&#xD;
             the exception of basal cell carcinoma or cervical cancer in situ.&#xD;
&#xD;
          7. Life expectancy of less than 12 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guanghui Gao</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji University Affiliated Shanghai Pulmonary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chunxia Su</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji University Affiliated Shanghai Pulmonary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoxia Chen</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji University Affiliated Shanghai Pulmonary Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Li</last_name>
    <role>Study Chair</role>
    <affiliation>Tongji University Affiliated Shanghai Pulmonary Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shengxiang Ren</last_name>
    <email>harry_ren@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Caicun Zhou</last_name>
    <email>caicunzhoudr@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shengxiang Ren</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shengxiang Ren</last_name>
      <email>harry_ren@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Guanghui Gao</last_name>
      <email>ghgao103@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 7, 2014</last_update_submitted>
  <last_update_submitted_qc>October 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tongji University</investigator_affiliation>
    <investigator_full_name>Caicun Zhou</investigator_full_name>
    <investigator_title>Shanghai Pulmonary Hospital</investigator_title>
  </responsible_party>
  <keyword>small cell lung cancer</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>Nab-paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</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/NCT02262897
org study id: FK1401
nct id: NCT02262897
lead sponsor: 
has dmc: Yes
Patients with extensive disease(ED) small cell lung cancer is still have a dismal prognosis,
      even though the first line chemotherapy showing about 70% response rate. Most of the patients
      will relapse with in 6 months after the chemotherapy and the following therapy such as second
      line chemotherapy have a very limited efficacy to these patients. Currently, there is no
      standard 3rd line therapy for the patients with ED small cell lung cancer(SCLC).

      As the investigators know, Nab-paclitaxel had showing promising efficacy in several cases
      report in the patients with SCLC, the aim of this clinical trial is to investigate the
      efficacy and safety of nab-paclitaxel as a single agent in the SCLC patients with extensive
      disease and failed to first line/ second line chemotherapy.
Primary end point: Objective Response Rate(ORR)

      Secondary end point:

      Progression Free Survival(PFS), Overall Survival(OS), Side effects according to Common
      Terminology Criteria for Adverse Events(CTCAE) version 4.0 Quality Of Life(QOL) etc.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate
time frame: tumor assessment every 6-8 weeks after the initiation of chemotherapy, up to 24 months
description: To evaluate Objective response rate every 6-8 weeks after the initiation of chemotherapy and before the completion of chemotherapy
measure: Progression free survival
time frame: 24 months
description: PFS is evaluated in the 24 months since the treatment began
measure: overall survival
time frame: 24 months
description: evaluated in the 24th month since the treatment began
measure: Side effects
time frame: 24 months
description: evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
measure: Quality Of Life
time frame: 24 months
description: evaluated in the 24th month since the treatment began
arm group label: Nab-paclitaxel single agent
arm group type: Experimental
description: Nab-paclitaxel single agent, either in 130mg/m2 weekly regimen, d1,8,15 every 4 weeks or in 230mg/m2 d1 every 3 weeks
intervention type: Drug
intervention name: Nab-paclitaxel
description: Nab-paclitaxel weekly chemotherapy 130mg/m2, d1,8,15,every 4 week or Nab-paclitaxel chemotherapy once a time with a dose of 230 mg/m2 every 3 weeks
arm group label: Nab-paclitaxel single agent
other name: Albumin-bound paclitaxel， Abraxane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guanghui Gao
role: Study Chair
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
last name: Chunxia Su
role: Study Chair
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
last name: Xiaoxia Chen
role: Study Chair
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
last name: Wei Li
role: Study Chair
affiliation: Tongji University Affiliated Shanghai Pulmonary Hospital
last name: Shengxiang Ren
email: harry_ren@126.com
last name: Caicun Zhou
email: caicunzhoudr@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Tongji University
investigator full name: Caicun Zhou
investigator title: Shanghai Pulmonary Hospital
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel