<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/NCT01735409</url>
  </required_header>
  <id_info>
    <org_study_id>ABXDDP20101224</org_study_id>
    <nct_id>NCT01735409</nct_id>
  </id_info>
  <brief_title>Dose-finding Study of Abraxane in Combination With Cisplatin to Treat Advanced Nasopharyngeal Carcinoma</brief_title>
  <acronym>ABX-DDP-Dose</acronym>
  <official_title>A Single Center Phase IIa Study of Nanoparticle Albumin-bound Paclitaxel in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, non-randomized phase IIa study to determine the tolerance and safety&#xD;
      of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced&#xD;
      nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been&#xD;
      infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE&#xD;
      V4.0 and RECIST 1.1 respectively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in&#xD;
      southern and southeastern China, where the incidence rate has been documented between 10 and&#xD;
      150 cases per 100,000 population per year. For advanced or metastatic NPC, chemotherapy&#xD;
      remain the mainstay of treatment. The 130-nm albumin-bound formulation of paclitaxel&#xD;
      ([Abraxane, ABX ];Celgene,Summit,NJ) is a promising new agent with more efficient entry to&#xD;
      the tumor microenvironment via caveolae-mediated transcytosis and preferential uptake by&#xD;
      cancer cells. Superior activity of ABX-based regimens without the necessity for&#xD;
      antianaphylactic pretreatments been shown in various solid tumors compared with the&#xD;
      traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of&#xD;
      combination of ABX and cisplatin (DDP) has not been determined in patients with advanced NPC.&#xD;
      In this single center, non-randomized phase IIa study, investigators seek to determine the&#xD;
      maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ABX-DDP, and perform an&#xD;
      exploratory study of its efficacy as measured by tumor response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">June 2014</completion_date>
  <primary_completion_date type="Anticipated">March 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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 (ORR)</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Adverse Events</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">69</enrollment>
  <condition>Nasopharyngeal Neoplasms</condition>
  <arm_group>
    <arm_group_label>1-day regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2-day regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3-day regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX + DDP</intervention_name>
    <description>ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1</description>
    <arm_group_label>1-day regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX + DDP</intervention_name>
    <description>ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1</description>
    <arm_group_label>2-day regimen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX + DDP</intervention_name>
    <description>ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1</description>
    <arm_group_label>3-day regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven NPC diagnosis&#xD;
&#xD;
          -  Patients who failed the prior standard treatment or were intolerant of standard&#xD;
             treatment&#xD;
&#xD;
          -  Elder than 18 years old&#xD;
&#xD;
          -  Performance status 0-2&#xD;
&#xD;
          -  Patients previously treated with chemotherapy (those having received paclitaxel-based&#xD;
             regimen were not excluded)&#xD;
&#xD;
          -  Subjects with at least one measurable lesion (Tumor lesions that are situated in a&#xD;
             previously irradiated area could not be considered measurable).&#xD;
&#xD;
          -  Life expectancy over twelve weeks&#xD;
&#xD;
          -  Neutrophil &gt; 1.5X10^9/L, PLT &gt; 100X10^9/L, Hb ≥ 90 g／l, with normal hepatic&#xD;
             function(AST, ALT &lt; 2.5 x upper limit of normal , and bilirubin &lt; 1.0 x upper limit of&#xD;
             normal), with normal renal function (creatinine &lt; 1.5 x upper limit of normal or&#xD;
             creatinine clearance ≥ 60ml/min as calculated by the Cockcroft - Gault formula. )&#xD;
&#xD;
          -  Urine pregnancy test (-) within 1 weeks before enrollment or being able to take&#xD;
             effective contraceptive measures during the medication and six months after completion&#xD;
             of the trial for fertile women.&#xD;
&#xD;
          -  Being able to provide paraffin blocks or 5-7 slides of biopsy tumor tissues.&#xD;
&#xD;
          -  Amenable to regular follow-up and to comply with trial requirements.&#xD;
&#xD;
          -  Signed and dated informed consent before the start of specific protocol procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy to paclitaxel or docetaxel&#xD;
&#xD;
          -  Patient with central nervous system metastasis&#xD;
&#xD;
          -  Patient refusing participation or signing informed consent&#xD;
&#xD;
          -  Active clinically serious infections with an anticipated antibiotics treatment for&#xD;
             more than 4 weeks&#xD;
&#xD;
          -  Patient with life threatening medical condition such as congestive heart failure,&#xD;
             symptomatic coronary artery disease or heart block&#xD;
&#xD;
          -  Myocardial infarction that occurred within 3 months before enrollment&#xD;
&#xD;
          -  Had received chemotherapy, radiotherapy or other anti-cancer therapies within 3 weeks&#xD;
             before enrollment&#xD;
&#xD;
          -  With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity&#xD;
             Criteria for Adverse Events [NCI CTC] grade ≥ 2)&#xD;
&#xD;
          -  Previously received post-2nd line anti-cancer therapy&#xD;
&#xD;
          -  Previous or concurrent cancer that is distinct in primary site or histology from the&#xD;
             cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal&#xD;
             cell carcinoma, superficial bladder tumors[Ta, Tis &amp; T1] or any cancer curatively&#xD;
             treated &gt; 3 years prior to study entry.&#xD;
&#xD;
          -  History of immunodeficiency , including HIV testing positive or suffering from other&#xD;
             acquired and congenital immunodeficiency disease, or the history of organ transplants;&#xD;
&#xD;
          -  Patients receiving prior abraxane treatment during pregnancy or lactation period&#xD;
&#xD;
          -  Fertile women who failed to or are reluctant to take contraceptive measures or&#xD;
             pregnancy test&#xD;
&#xD;
          -  Men or his companion who are reluctant to take effective contraceptive measures during&#xD;
             the medication and six months after completion of the trial&#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>Li Zhang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>January 25, 2014</last_update_submitted>
  <last_update_submitted_qc>January 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 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>Li Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Advanced Nasopharyngeal Carcinoma</keyword>
  <keyword>Abraxane</keyword>
  <keyword>Cisplatin</keyword>
  <keyword>Dose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
  </condition_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/NCT01735409
org study id: ABXDDP20101224
nct id: NCT01735409
lead sponsor: 
has dmc: Yes
This is a single center, non-randomized phase IIa study to determine the tolerance and safety
      of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced
      nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been
      infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE
      V4.0 and RECIST 1.1 respectively.
Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in
      southern and southeastern China, where the incidence rate has been documented between 10 and
      150 cases per 100,000 population per year. For advanced or metastatic NPC, chemotherapy
      remain the mainstay of treatment. The 130-nm albumin-bound formulation of paclitaxel
      ([Abraxane, ABX ];Celgene,Summit,NJ) is a promising new agent with more efficient entry to
      the tumor microenvironment via caveolae-mediated transcytosis and preferential uptake by
      cancer cells. Superior activity of ABX-based regimens without the necessity for
      antianaphylactic pretreatments been shown in various solid tumors compared with the
      traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of
      combination of ABX and cisplatin (DDP) has not been determined in patients with advanced NPC.
      In this single center, non-randomized phase IIa study, investigators seek to determine the
      maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ABX-DDP, and perform an
      exploratory study of its efficacy as measured by tumor response.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: 24 months
measure: Progression free survival (PFS)
time frame: 24 months
measure: Number of Participants with Adverse Events
time frame: 24 months
arm group label: 1-day regimen
arm group type: Experimental
description: ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
arm group label: 2-day regimen
arm group type: Experimental
description: ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
arm group label: 3-day regimen
arm group type: Experimental
description: ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
intervention type: Drug
intervention name: ABX + DDP
description: ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
arm group label: 1-day regimen
intervention type: Drug
intervention name: ABX + DDP
description: ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
arm group label: 2-day regimen
intervention type: Drug
intervention name: ABX + DDP
description: ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
arm group label: 3-day regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Li Zhang, MD
role: Principal Investigator
affiliation: Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Li Zhang
investigator title: Professor
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma
mesh term: Nasopharyngeal Neoplasms