<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/NCT02183246</url>
  </required_header>
  <id_info>
    <org_study_id>1164.4</org_study_id>
    <nct_id>NCT02183246</nct_id>
  </id_info>
  <brief_title>Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients</brief_title>
  <official_title>A Phase III, Double-Blind, Randomized, Placebo-Controlled Study of Porfiromycin Used as an Adjuvant to Radiation Therapy in Postoperative Head and Neck Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to&#xD;
      radiotherapy in postoperative head and neck a cancer patients as well as assessment of&#xD;
      population pharmacokinetic parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 2000</start_date>
  <primary_completion_date type="Actual">December 2000</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Disease Progression</measure>
    <time_frame>week 4 and 8 post treatment, every 8 weeks until end of study</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum toxicity grades of Adverse Events (AE)</measure>
    <time_frame>until 42 days after end of treatment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to non-accidental death</measure>
    <time_frame>week 4 and 8 post treatment, every 8 weeks until end of study</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum porfiromycin concentration-time profile</measure>
    <time_frame>up to week 7</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death for any reason</measure>
    <time_frame>4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss of local or regional control, distant metastasis or death for any reason</measure>
    <time_frame>4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss of local or regional control or distant metastasis</measure>
    <time_frame>4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss of local or regional control</measure>
    <time_frame>4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of Adverse Events</measure>
    <time_frame>up to week 16</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant changes in laboratory tests</measure>
    <time_frame>up to week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in Patients health related Quality of life-Questionnaires</measure>
    <time_frame>week 1, 5, 7, 4 weeks post treatment, every 12 weeks until end of study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Head and Neck Neoplasms</condition>
  <arm_group>
    <arm_group_label>Porfiromycin + Radiotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Radiotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Porfiromycin</intervention_name>
    <arm_group_label>Porfiromycin + Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo + Radiotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <arm_group_label>Placebo + Radiotherapy</arm_group_label>
    <arm_group_label>Porfiromycin + Radiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female postoperative radical neck surgery patients with histologically proven&#xD;
             Stage III or IV (without distant metastases) epidermoid (squamous cell) carcinoma of&#xD;
             the head and neck limited to the following locations as defined by the American Joint&#xD;
             Commission (AJC): lip and oral cavity, pharynx, or larynx.&#xD;
&#xD;
          -  Postoperative radical patients whose specimen had a) microscopic positive tumor cell&#xD;
             margins (&lt; 2mm from surgical margin) or b) extranodal capsular spread&#xD;
             (perineural-vascular embolization) or c) two or more positive nodes&#xD;
&#xD;
          -  Postoperative radical neck patients must have received Radiotherapy (RT).&#xD;
&#xD;
          -  Performance status of ≥ 70 on the Karnofsky Performance Score (KPS) at screening.&#xD;
&#xD;
          -  Patients ≥ 18 years of age&#xD;
&#xD;
          -  Patients must have provided written informed consent prior to participation in the&#xD;
             trial.&#xD;
&#xD;
          -  Patients must have demonstrated an educational level and a degree of understanding&#xD;
             such that they could communicate effectively with the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that received any prior chemotherapy including mitomycin-C or porfiromycin.&#xD;
&#xD;
          -  Treatment with granulocyte, granulocyte-macrophage stimulating factor (G-CSF, GM-CSF)&#xD;
             or Interleukin-11 within 30 days prior to start of RT.&#xD;
&#xD;
          -  RT within the treatment field for any malignancy within the past five years.&#xD;
&#xD;
          -  Patients who had any gross (visible or palpable) residual disease left after surgery.&#xD;
&#xD;
          -  Patients who met any of the following clinical laboratory criteria upon screening:&#xD;
&#xD;
               1. Granulocyte (neutrophil) count of &lt; 1,500/cubic millimeters (mm3)&#xD;
&#xD;
               2. Platelets &lt; 75,000/mm3&#xD;
&#xD;
               3. Prothrombin time (PT) and partial thromboplastin time (PTT) &gt; 1.5 times the upper&#xD;
                  limit of normal (ULN) in seconds.&#xD;
&#xD;
          -  Women who were pregnant or nursing.&#xD;
&#xD;
          -  Women of childbearing potential who were unwilling to utilise a medically acceptable&#xD;
             method of contraception (oral contraceptives, intrauterine devices, diaphragm or&#xD;
             subdermal implants eg: Norplant®).&#xD;
&#xD;
          -  Other malignancies active within the past five years (other than basal or squamous&#xD;
             cell carcinomas of the skin outside the planned radiation portals, or in situ&#xD;
             carcinoma of the cervix).&#xD;
&#xD;
          -  The presence of more than one primary tumor or presence of distant metastases.&#xD;
&#xD;
          -  The presence of any other life-threatening illness, such a severe chronic lung, liver,&#xD;
             or heart disease that would be expected to be fatal within five years, regardless of&#xD;
             the patient's cancer status.&#xD;
&#xD;
          -  Patients who participated in a clinical trial with another investigational drug or&#xD;
             treatment 30 days prior to screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1164/1164.4_U01-3121.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 4, 2014</last_update_submitted>
  <last_update_submitted_qc>July 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 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>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Porfiromycin</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/NCT02183246
org study id: 1164.4
nct id: NCT02183246
lead sponsor: 
Determination of efficacy and safety of porfiromycin versus placebo as an adjuvant to
      radiotherapy in postoperative head and neck a cancer patients as well as assessment of
      population pharmacokinetic parameters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Time to Disease Progression
time frame: week 4 and 8 post treatment, every 8 weeks until end of study
measure: Maximum toxicity grades of Adverse Events (AE)
time frame: until 42 days after end of treatment
measure: Time to non-accidental death
time frame: week 4 and 8 post treatment, every 8 weeks until end of study
measure: Serum porfiromycin concentration-time profile
time frame: up to week 7
measure: Death for any reason
time frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
measure: Loss of local or regional control, distant metastasis or death for any reason
time frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
measure: Loss of local or regional control or distant metastasis
time frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
measure: Loss of local or regional control
time frame: 4 weeks post treatment for every 8 weeks through 48 weeks, every 12 weeks until end of study
measure: Occurrence of Adverse Events
time frame: up to week 16
measure: Significant changes in laboratory tests
time frame: up to week 7
measure: Changes from baseline in Patients health related Quality of life-Questionnaires
time frame: week 1, 5, 7, 4 weeks post treatment, every 12 weeks until end of study
arm group label: Porfiromycin + Radiotherapy
arm group type: Experimental
arm group label: Placebo + Radiotherapy
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Porfiromycin
arm group label: Porfiromycin + Radiotherapy
intervention type: Drug
intervention name: Placebo
arm group label: Placebo + Radiotherapy
intervention type: Radiation
intervention name: Radiotherapy
arm group label: Placebo + Radiotherapy
arm group label: Porfiromycin + Radiotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1164/1164.4_U01-3121.pdf
description: Related Info
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Porfiromycin