<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/NCT01711112</url>
  </required_header>
  <id_info>
    <org_study_id>2010-03-072</org_study_id>
    <nct_id>NCT01711112</nct_id>
  </id_info>
  <brief_title>Salvage Docetaxel for Pretreated Urothelial Cancer</brief_title>
  <official_title>A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on the previous clinical experience in other cancers, and considering the absence of&#xD;
      current standard salvage regimens, the single agent docetaxel is selected as the regimen for&#xD;
      this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe&#xD;
      myelosuppression observed in other cancer trials warrants further study in urothelial cancer.&#xD;
      The objective of the study is to evaluate the safety and activity of weekly docetaxel given&#xD;
      as salvage therapy for advanced urothelial cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study scheme&#xD;
&#xD;
      Patients eligible for this study will be offered participation. Screening numbers are endowed&#xD;
      to all subjects who sign the informed consent forms. These screening numbers are used as&#xD;
      'Subject Identification Code&quot; along with subject initials. Subjects withdrawn from the study&#xD;
      retain their screening number.&#xD;
&#xD;
      Patients will have study drug discontinued at the time of progression and will then remain on&#xD;
      study for a 4-week safety follow-up. Those without progression may continue to receive&#xD;
      docetaxel as long as this is considered to be in their interest by their physician. After&#xD;
      progression, patients will remain on study for the purpose of collecting follow-up and&#xD;
      survival information.&#xD;
&#xD;
      VII-3. Study treatment&#xD;
&#xD;
      The study drug doses should be calculated taking the body surface area into consideration.&#xD;
      Docetaxel 30 mg/m2 will be administered on days 1 and 8 every 3 weeks. Docetaxel will be&#xD;
      diluted in 250 ml 0.9% saline or 5% dextrose to produce a final solution with concentration&#xD;
      of 0.3-0.74 mg/ml. It will be administered as an infusion over 60 min on each infusion day.&#xD;
      Patients will be premedicated with iv dexamethasone 15 mg, antihistamines and a prophylactic&#xD;
      antiemetic treatment prior to docetaxel infusion in order to reduce the incidence and&#xD;
      severity of fluid retention as well as the severity of hypersensitivity reactions. Patients&#xD;
      experiencing adverse events attributed to irinotecan should have treatment delay as needed&#xD;
      and/or may be interrupted or reduced depending on individual tolerability and according to&#xD;
      the protocol.&#xD;
&#xD;
      Treatment will be continued until disease progression, unacceptable toxicities, or consent&#xD;
      withdrawal. After failure of study treatment, further treatment can be administered at the&#xD;
      discretion of investigators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</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>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants with Adverse Events as a Measure of Safety and Tolerability</measure>
    <time_frame>every 3 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>docetaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Days 1 &amp; 8 Docetaxel 35 mg/m2 IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Treatment will be continued until progression, unacceptable toxicity, or refusal</description>
    <arm_group_label>docetaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged over 20 years or older&#xD;
&#xD;
          -  histologically confirmed metastatic and/or unresectable urothelial carcinoma arising&#xD;
             from bladder, ureter, or renal pelvis&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  measurable disease, or evaluable lesion(s), as defined by RECIST&#xD;
&#xD;
          -  clinical failure of the prior chemotherapy for advanced disease, including gemcitabine&#xD;
             and platinum&#xD;
&#xD;
          -  adequate major organ functions&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe co-morbid illness and/or active infections&#xD;
&#xD;
          -  prior treatment with taxanes (paclitaxel and docetaxel)&#xD;
&#xD;
          -  any patients judged by the investigator to be unfit to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Soon Il Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dankook University Hospital, Cheonan, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-gu</state>
        <zip>135710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>May 14, 2014</last_update_submitted>
  <last_update_submitted_qc>May 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Docetaxel</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/NCT01711112
org study id: 2010-03-072
nct id: NCT01711112
lead sponsor: 
has dmc: No
Based on the previous clinical experience in other cancers, and considering the absence of
      current standard salvage regimens, the single agent docetaxel is selected as the regimen for
      this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe
      myelosuppression observed in other cancer trials warrants further study in urothelial cancer.
      The objective of the study is to evaluate the safety and activity of weekly docetaxel given
      as salvage therapy for advanced urothelial cancer.
Study scheme

      Patients eligible for this study will be offered participation. Screening numbers are endowed
      to all subjects who sign the informed consent forms. These screening numbers are used as
      'Subject Identification Code" along with subject initials. Subjects withdrawn from the study
      retain their screening number.

      Patients will have study drug discontinued at the time of progression and will then remain on
      study for a 4-week safety follow-up. Those without progression may continue to receive
      docetaxel as long as this is considered to be in their interest by their physician. After
      progression, patients will remain on study for the purpose of collecting follow-up and
      survival information.

      VII-3. Study treatment

      The study drug doses should be calculated taking the body surface area into consideration.
      Docetaxel 30 mg/m2 will be administered on days 1 and 8 every 3 weeks. Docetaxel will be
      diluted in 250 ml 0.9% saline or 5% dextrose to produce a final solution with concentration
      of 0.3-0.74 mg/ml. It will be administered as an infusion over 60 min on each infusion day.
      Patients will be premedicated with iv dexamethasone 15 mg, antihistamines and a prophylactic
      antiemetic treatment prior to docetaxel infusion in order to reduce the incidence and
      severity of fluid retention as well as the severity of hypersensitivity reactions. Patients
      experiencing adverse events attributed to irinotecan should have treatment delay as needed
      and/or may be interrupted or reduced depending on individual tolerability and according to
      the protocol.

      Treatment will be continued until disease progression, unacceptable toxicities, or consent
      withdrawal. After failure of study treatment, further treatment can be administered at the
      discretion of investigators.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response rate
time frame: 6 weeks
measure: progression-free survival
time frame: 6 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: every 3 weeks
arm group label: docetaxel
arm group type: Experimental
description: Days 1 & 8 Docetaxel 35 mg/m2 IV
intervention type: Drug
intervention name: Docetaxel
description: Treatment will be continued until progression, unacceptable toxicity, or refusal
arm group label: docetaxel
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Soon Il Lee, MD
role: Principal Investigator
affiliation: Dankook University Hospital, Cheonan, Korea
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
mesh term: Docetaxel