<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/NCT01693718</url>
  </required_header>
  <id_info>
    <org_study_id>12141B</org_study_id>
    <nct_id>NCT01693718</nct_id>
  </id_info>
  <brief_title>A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer</brief_title>
  <official_title>A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study is to test a particular combination of drugs and determine their&#xD;
      ability to completely eliminate head and neck cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2003</start_date>
  <completion_date type="Actual">September 2004</completion_date>
  <primary_completion_date type="Actual">September 2003</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 Rates</measure>
    <time_frame>2-5 years</time_frame>
    <description>To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of administering adjuvant CRA and interferon alfa2a</measure>
    <time_frame>2-5 years</time_frame>
    <description>To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of study regimen</measure>
    <time_frame>2-5 years</time_frame>
    <description>To determine the pattern and degree of clinical toxicity of this regimen</description>
  </secondary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Head and Neck</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hydroxyurea</intervention_name>
    <description>Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>5- Fluorouracil</intervention_name>
    <description>Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs.&#xD;
Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy.</description>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output &gt; 100 cc/ hour.</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Eligibility Criteria:&#xD;
&#xD;
          1. Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx,&#xD;
             larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients&#xD;
             with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also&#xD;
             eligible. Therapy is given with curative intent.&#xD;
&#xD;
             Prior to entry in the study the resectability and standard treatment options for each&#xD;
             patient will be determined during a joint evaluation by a team composed of an&#xD;
             attending surgeon, a radiation oncologist and a medical oncologist. In addition the&#xD;
             timing and feasibility of surgery will be determined in each patient prior to&#xD;
             initiation of therapy. The unequivocal demonstration of distant metastasis confers in&#xD;
             eligibility.&#xD;
&#xD;
          2. Measurable disease is not required, but all disease will be carefully evaluated.&#xD;
&#xD;
          3. Patients must have a histologically or cytologically confirmed diagnosis of squamous&#xD;
             cell carcinoma or lymphoepithelioma.&#xD;
&#xD;
          4. Patients must have not received prior chemotherapy or radiotherapy.&#xD;
&#xD;
          5. Patients must have performance status of &gt;60%&#xD;
&#xD;
          6. Patients must have a WBC count of &gt;3.5, an ANC count &gt;1500 and a platlet count of&#xD;
             &gt;100,000.&#xD;
&#xD;
          7. The serum creatinine must be equal to or less than 1.5 m/dlor the calculated&#xD;
             creatinine clearance must exceed 50cc/min.&#xD;
&#xD;
          8. Patient must be free of significant infection or other severe complicating medical&#xD;
             illness.&#xD;
&#xD;
          9. Pregnancy will constitute an absolute contraindication to entrance on this protocol.&#xD;
             Females of child-bearing age should be using adequate contraception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>59 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Everett Vokes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Chicago Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>August 20, 2010</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 4, 2013</last_update_submitted>
  <last_update_submitted_qc>September 4, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cancer</keyword>
  <keyword>advanced</keyword>
  <keyword>oral cavity</keyword>
  <keyword>larynx</keyword>
  <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>Fluorouracil</mesh_term>
    <mesh_term>Hydroxyurea</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/NCT01693718
org study id: 12141B
nct id: NCT01693718
lead sponsor: 
has dmc: Yes
The goal of the study is to test a particular combination of drugs and determine their
      ability to completely eliminate head and neck cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Response Rates
time frame: 2-5 years
description: To evaluate the activity of 5 cycles of C-FHX/G-CSF in previously untreated patients with stage II and IV locoregionally advanced head and neck cancer.
measure: Feasibility of administering adjuvant CRA and interferon alfa2a
time frame: 2-5 years
description: To determine the feasibility of administering adjuvant CRA and interferon alfa2a for up to one or until tumor progression in patients completing local therapy.
measure: Side effects of study regimen
time frame: 2-5 years
description: To determine the pattern and degree of clinical toxicity of this regimen
intervention type: Drug
intervention name: Hydroxyurea
description: Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.
intervention type: Drug
intervention name: 5- Fluorouracil
description: Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs.
Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy.
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output > 100 cc/ hour.
criteria: 
gender: All
minimum age: 59 Years
maximum age: N/A
healthy volunteers: No
last name: Everett Vokes, MD
role: Principal Investigator
affiliation: The University of Chicago Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
mesh term: Fluorouracil
mesh term: Hydroxyurea