<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/NCT01719302</url>
  </required_header>
  <id_info>
    <org_study_id>VCC 1202</org_study_id>
    <nct_id>NCT01719302</nct_id>
  </id_info>
  <brief_title>Docetaxel, Gemcitabine and Pazopanib as Treatment for Soft Tissue Sarcoma</brief_title>
  <official_title>Phase I/II Study of the Combination of Docetaxel, Gemcitabine and Pazopanib for Neoadjuvant Treatment of Patients With Operable Soft Tissue Sarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Vermont</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients&#xD;
      with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine&#xD;
      kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.&#xD;
&#xD;
      The Phase I component of this study is designed to determine the maximum tolerated dose of&#xD;
      pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to&#xD;
      determine the overall response rate of the combination of docetaxel, gemcitabine and&#xD;
      pazopanib prior to surgical resection in patients with soft tissue sarcoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>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>Maximum Tolerated Dose</measure>
    <time_frame>1 cycle (28 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>4 cycles (112 days)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Stage III Adult Soft Tissue Sarcoma</condition>
  <arm_group>
    <arm_group_label>cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles</description>
    <arm_group_label>cohort 1</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles</description>
    <arm_group_label>cohort 1</arm_group_label>
    <other_name>Taxotere</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pazopanib</intervention_name>
    <description>Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.</description>
    <arm_group_label>cohort 1</arm_group_label>
    <other_name>Votrient</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  chemotherapy naive, histologically high grade soft tissue sarcoma that is considered&#xD;
             to be operable&#xD;
&#xD;
          -  tumor greater than 5 cm in longest dimension&#xD;
&#xD;
          -  life expectancy of at least 6 months&#xD;
&#xD;
          -  Zubrod performance status of 0-2&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  adequate bone marrow function defined by:&#xD;
&#xD;
               1. absolute peripheral granulocyte count of &gt;1500 cells/mm^3&#xD;
&#xD;
               2. hemoglobin &gt;8.0 g/dl&#xD;
&#xD;
               3. platelet count &gt;100,000/mm^3&#xD;
&#xD;
               4. absence of a regular red blood cell transfusion requirement&#xD;
&#xD;
          -  adequate hepatic function defined by:&#xD;
&#xD;
               1. total bilirubin &lt;1.5 x upper limit of normal (ULN)&#xD;
&#xD;
               2. AST, ALT and alkaline phosphatase all not more than 2.5 x ULN&#xD;
&#xD;
          -  adequate renal function defined by:&#xD;
&#xD;
             1. serum creatinine &lt;1.5 x ULN&#xD;
&#xD;
          -  negative pregnancy test for women of child bearing potential&#xD;
&#xD;
          -  willingness to use effective contraception while on treatment and for 3 months&#xD;
             thereafter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple metastases (patients with 5 or fewer oligometastases that could be resectable&#xD;
             are eligible)&#xD;
&#xD;
          -  Pregnant women or nursing mothers&#xD;
&#xD;
          -  concurrent chemotherapy or radiation therapy&#xD;
&#xD;
          -  severe medical problems (at the discretion of the investigator)&#xD;
&#xD;
          -  history of severe hypersensitivity reaction to docetaxel or other drugs formulated&#xD;
             with polysorbate 80&#xD;
&#xD;
          -  symptomatic brain metastases&#xD;
&#xD;
          -  cirrhosis&#xD;
&#xD;
          -  dermatofibrosarcoma protuberans (DFSP), embryonal rhabdomyosarcoma or alveolar soft&#xD;
             part sarcoma (ASPS)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Fletcher Allen Health Care</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>June 14, 2016</last_update_submitted>
  <last_update_submitted_qc>June 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Claire Verschraegen</investigator_full_name>
    <investigator_title>Director, Hematology Oncology Unit</investigator_title>
  </responsible_party>
  <keyword>Soft tissue sarcoma</keyword>
  <keyword>gemcitabine</keyword>
  <keyword>docetaxel</keyword>
  <keyword>pazopanib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 10, 2017</submitted>
    <returned>April 20, 2017</returned>
  </pending_results>
  <!-- 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/NCT01719302
org study id: VCC 1202
nct id: NCT01719302
lead sponsor: 
collaborator: 
has dmc: No
Chemotherapy treatment with docetaxel and gemcitabine is a standard treatment for patients
      with soft tissue sarcoma. This study is designed to explore whether the addition of tyrosine
      kinase inhibitor pazopanib enhances the anticancer effect of the chemotherapy drugs.

      The Phase I component of this study is designed to determine the maximum tolerated dose of
      pazopanib when given with docetaxel and gemcitabine. The Phase II component is designed to
      determine the overall response rate of the combination of docetaxel, gemcitabine and
      pazopanib prior to surgical resection in patients with soft tissue sarcoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Tolerated Dose
time frame: 1 cycle (28 days)
measure: Overall response rate
time frame: 4 cycles (112 days)
arm group label: cohort 1
arm group type: Experimental
intervention type: Drug
intervention name: Gemcitabine
description: 1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
arm group label: cohort 1
other name: Gemzar
intervention type: Drug
intervention name: Docetaxel
description: 50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
arm group label: cohort 1
other name: Taxotere
intervention type: Drug
intervention name: Pazopanib
description: Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.
arm group label: cohort 1
other name: Votrient
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Claire Verschraegen
investigator title: Director, Hematology Oncology Unit
mesh term: Sarcoma
mesh term: Gemcitabine
mesh term: Docetaxel
submitted: March 10, 2017
returned: April 20, 2017