<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/NCT01670799</url>
  </required_header>
  <id_info>
    <org_study_id>INST 1115</org_study_id>
    <secondary_id>NCI-2012-00917</secondary_id>
    <nct_id>NCT01670799</nct_id>
  </id_info>
  <brief_title>Availability &amp; Effect of Post-OP Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer</brief_title>
  <official_title>A Pilot Trial to Study the Availability and Effect of Post-OP IV Ketorolac on Ovarian, Fallopian Tube or Primary Peritoneal Cancer, Cells Retrieved From the Peritoneal Cavity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New Mexico Cancer Care Alliance</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>New Mexico Cancer Care Alliance</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the anti-cancer effect of a pain medication called&#xD;
      ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after&#xD;
      surgery for ovarian, fallopian tube or primary peritoneal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian cancer is the sixth most common cancer and the seventh most common cause of cancer&#xD;
      deaths in women across the globe. The majority of women, nearly 70%, will present with&#xD;
      advanced stage disease that heralds a poor prognosis.&#xD;
&#xD;
      Despite aggressive treatment that still favors initial debulking surgery followed by a&#xD;
      platinum and taxane based chemotherapy regimen, most patients relapse after achieving a&#xD;
      complete clinical response.&#xD;
&#xD;
      Our group has shown that the ketorolac can inhibit gene activity which inhibits cell&#xD;
      proliferation and migration.Ketorolac will be used in this study with the goal of producing&#xD;
      specific inhibition of cell adhesion and migration in ovarian cancer cells retrieved within&#xD;
      the peritoneal cavity after cytoreductive surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Early Phase 1</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure levels of Ketorolac in peritoneal cavity</measure>
    <time_frame>24 hours</time_frame>
    <description>To determine the concentration of measurable levels of R and S- Ketorolac (and the percent racemic mixture) in the peritoneal cavity after intravenous (IV) administration in the post-operative patient after cytoreductive surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration</measure>
    <time_frame>Up to 48 hours</time_frame>
    <description>The secondary endpoint of this study is to determine the effect of IV ketorolac on cell adhesion and migration of ovarian cancer cells retrieved from the peritoneal cavity after cytoreductive surgery</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Peritoneal Cavity Cancer</condition>
  <arm_group>
    <arm_group_label>Ketorolac</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive a single dose of IV ketorolac for pain management for the indication of post-operative pain control. Patients less than 65 years of age and in otherwise good health will receive a 30mg IV single dose. Patients 65 years of age or greater, or who have mild renal insufficiency or are of low weight (as per section 3.2) will receive a single 15 mg dose IV ketorolac.&#xD;
In patients who have a clinical pain response and have no contraindications to multi-dose (every 6 hours over 24 hours), additional doses will be given per physician discretion based on clinical indication. Patients receiving 24 hour dosing will be eligible for sample time points after 24 hour dosing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>This is a pilot (feasibility) trial to determine the availability, concentration and racemic mixture of a clinically indicated pain medication, ketorolac, in the peritoneal cavity and the subsequent effect on free floating ovarian cancer cells in patients after cytoreductive surgery for ovarian cancer.</description>
    <arm_group_label>Ketorolac</arm_group_label>
    <other_name>Ketorolac tromethamine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (PRE-OPERATIVE [OP])&#xD;
&#xD;
          -  Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary&#xD;
             peritoneal cancer with a planned cytoreductive surgery&#xD;
&#xD;
          -  Borderline ovarian cancer with ascites&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG)/Zubrod/ Southwest Oncology Group (SWOG)&#xD;
             performance status &lt; 2 (Karnofsky performance status &gt;= 70%)&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Absolute neutrophil count &gt; 1000/uL&#xD;
&#xD;
          -  Platelet count &gt; 100'000/uL&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x upper limit of normal (ULN)&#xD;
&#xD;
          -  Bilirubin =&lt; 1.5 x normal&#xD;
&#xD;
          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or&#xD;
             serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels =&lt;&#xD;
             2 x ULN&#xD;
&#xD;
          -  No known bleeding disorders&#xD;
&#xD;
          -  No known sensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)&#xD;
&#xD;
          -  No active peptic ulcer disease&#xD;
&#xD;
          -  No active bleeding&#xD;
&#xD;
          -  SECONDARY ELIGIBILITY&#xD;
&#xD;
          -  Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal&#xD;
             cancer on frozen section diagnosis&#xD;
&#xD;
          -  Placement of an intraperitoneal port at the time of surgery for anticipated use for&#xD;
             adjuvant chemotherapy or management of post-operative ascites&#xD;
&#xD;
          -  If epidural catheter was used - the catheter must be removed prior to treatment&#xD;
&#xD;
          -  No active bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-epithelial ovarian cancer or metastatic cancer to the ovaries&#xD;
&#xD;
          -  Borderline ovarian cancer without ascites&#xD;
&#xD;
          -  Presumed early stage ovarian cancer&#xD;
&#xD;
          -  No clinical indication for a peritoneal port&#xD;
&#xD;
          -  Active use of an epidural catheter&#xD;
&#xD;
          -  Uncontrolled or unstable medical conditions&#xD;
&#xD;
          -  Off study use of ketorolac or other NSAIDs prior to study administration&#xD;
&#xD;
          -  Active bleeding or high risk of bleeding&#xD;
&#xD;
          -  Active therapeutic anticoagulation&#xD;
&#xD;
          -  Known hypersensitivity to NSAIDs&#xD;
&#xD;
          -  Chronic or acute renal insufficiency as defined by a preoperative serum creatinine&#xD;
             greater than 1.5mg/dL or creatinine clearance of &lt; 60 ml/min&#xD;
&#xD;
          -  Any co-morbid condition that' in the view of the attending physician' renders the&#xD;
             patient at high risk from treatment complications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carolyn Muller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UNM Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.unm.edu</url>
    <description>UNM Cancer Center website</description>
  </link>
  <link>
    <url>http://www.nmcca.org</url>
    <description>New Mexico Cancer Care Alliance website</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ketorolac</keyword>
  <keyword>Bioavailability</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Ketorolac Tromethamine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 29, 2013</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT01670799/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT01670799
org study id: INST 1115
secondary id: NCI-2012-00917
nct id: NCT01670799
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the anti-cancer effect of a pain medication called
      ketorolac (Toradol) on ovarian cancer cells in the abdominal (peritoneal) cavity after
      surgery for ovarian, fallopian tube or primary peritoneal cancer.
Ovarian cancer is the sixth most common cancer and the seventh most common cause of cancer
      deaths in women across the globe. The majority of women, nearly 70%, will present with
      advanced stage disease that heralds a poor prognosis.

      Despite aggressive treatment that still favors initial debulking surgery followed by a
      platinum and taxane based chemotherapy regimen, most patients relapse after achieving a
      complete clinical response.

      Our group has shown that the ketorolac can inhibit gene activity which inhibits cell
      proliferation and migration.Ketorolac will be used in this study with the goal of producing
      specific inhibition of cell adhesion and migration in ovarian cancer cells retrieved within
      the peritoneal cavity after cytoreductive surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Measure levels of Ketorolac in peritoneal cavity
time frame: 24 hours
description: To determine the concentration of measurable levels of R and S- Ketorolac (and the percent racemic mixture) in the peritoneal cavity after intravenous (IV) administration in the post-operative patient after cytoreductive surgery.
measure: Measure effect of IV Ketorolac on ovarian cancer cell adhesion and migration
time frame: Up to 48 hours
description: The secondary endpoint of this study is to determine the effect of IV ketorolac on cell adhesion and migration of ovarian cancer cells retrieved from the peritoneal cavity after cytoreductive surgery
arm group label: Ketorolac
arm group type: Experimental
description: All patients will receive a single dose of IV ketorolac for pain management for the indication of post-operative pain control. Patients less than 65 years of age and in otherwise good health will receive a 30mg IV single dose. Patients 65 years of age or greater, or who have mild renal insufficiency or are of low weight (as per section 3.2) will receive a single 15 mg dose IV ketorolac.
In patients who have a clinical pain response and have no contraindications to multi-dose (every 6 hours over 24 hours), additional doses will be given per physician discretion based on clinical indication. Patients receiving 24 hour dosing will be eligible for sample time points after 24 hour dosing.
intervention type: Drug
intervention name: Ketorolac
description: This is a pilot (feasibility) trial to determine the availability, concentration and racemic mixture of a clinically indicated pain medication, ketorolac, in the peritoneal cavity and the subsequent effect on free floating ovarian cancer cells in patients after cytoreductive surgery for ovarian cancer.
arm group label: Ketorolac
other name: Ketorolac tromethamine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carolyn Muller, MD
role: Principal Investigator
affiliation: UNM Cancer Center
facility: 
country: United States
url: http://cancer.unm.edu
description: UNM Cancer Center website
url: http://www.nmcca.org
description: New Mexico Cancer Care Alliance website
responsible party type: Sponsor
mesh term: Fallopian Tube Neoplasms
mesh term: Ketorolac
mesh term: Ketorolac Tromethamine
provided document: 