<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/NCT03253133</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-URC2015/34</org_study_id>
    <nct_id>NCT03253133</nct_id>
  </id_info>
  <brief_title>Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC</brief_title>
  <acronym>NIPOX</acronym>
  <official_title>Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study determine the maximal tolerate dose&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study determine the maximal tolerate dose for the patient treated by intraperitoneal&#xD;
      chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2016</start_date>
  <completion_date type="Actual">April 24, 2023</completion_date>
  <primary_completion_date type="Actual">October 28, 2020</primary_completion_date>
  <phase>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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum tolerated dose</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
    <description>To determine:&#xD;
- Maximum tolerated dose (MTD),</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Curve (AUC)</measure>
    <time_frame>through study completion, an average of 3 year</time_frame>
    <description>To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Oxaliplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IP neoadjuvant chemotherapy protocol:&#xD;
Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.&#xD;
Intravenous chemotherapy protocol:&#xD;
Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Dose levels of Oxaliplatin:&#xD;
4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1&#xD;
Table 1: Dose levels&#xD;
Dose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 * 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6&#xD;
* Start level</description>
    <arm_group_label>Oxaliplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LV5FU or Folfiri</intervention_name>
    <description>Association of chemotherapy by LV5FU or Folfiri according pratician choice</description>
    <arm_group_label>Oxaliplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxycodone</intervention_name>
    <description>Oxycodone</description>
    <arm_group_label>Oxaliplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged over 18 years old&#xD;
&#xD;
          2. Histologically confirmed diagnosis of colorectal or appendix cancer&#xD;
&#xD;
          3. Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally&#xD;
             resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI&#xD;
             (Magnetic Resonance Imaging)) or during a previous abdominal surgery&#xD;
&#xD;
          4. Peritoneal Carcinomatosis Index &gt; 17&#xD;
&#xD;
          5. Previous adjuvant chemotherapy is allowed&#xD;
&#xD;
          6. One or several lines of chemotherapy are allowed&#xD;
&#xD;
          7. Hemoglobin ≥ 10 g/dL (red blood transfusion is allowed if needed), neutrophils ≥&#xD;
             1.500/mm3, platelets ≥ 100.000/mm3 and white blood cells &gt; 3000 /mm3&#xD;
&#xD;
          8. Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN&#xD;
&#xD;
          9. Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥&#xD;
             LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN&#xD;
&#xD;
         10. ECOG (Eastern Cooperative Oncology group) &lt; 1&#xD;
&#xD;
         11. Life expectancy higher than 8 weeks&#xD;
&#xD;
         12. Negative pregnancy test in women of childbearing potential&#xD;
&#xD;
         13. Use of an effective contraceptive method during the whole treatment and up to 6 months&#xD;
             after the completion of treatment&#xD;
&#xD;
         14. Patients affiliated to a French Social Security System&#xD;
&#xD;
         15. Signed informed consent (IC) obtained before any study specific procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serum uracile ≥ 16 ng/ml&#xD;
&#xD;
          2. Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal&#xD;
             nodes)&#xD;
&#xD;
          3. Patients with anesthetic or medical contraindications to surgery&#xD;
&#xD;
          4. Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF&#xD;
&#xD;
          5. Patients previously treated with cytoreduction and followed by an intra-peritoneal&#xD;
             chemotherapy within the past 6 months.&#xD;
&#xD;
          6. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant&#xD;
             systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion&#xD;
&#xD;
          7. History or presence of other cancer within the past 5 years (except adequately treated&#xD;
             in situ carcinoma of the cervix and non-melanoma skin cancer)&#xD;
&#xD;
          8. Pregnant or breastfeeding women&#xD;
&#xD;
          9. Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or&#xD;
             patients with untreated serious infections&#xD;
&#xD;
         10. Participation in another clinical trial within 30 days prior to study entry&#xD;
&#xD;
         11. Legal incapacity or physical, psychological or mental status interfering with the&#xD;
             patient's ability to sign the informed consent or to terminate the study&#xD;
&#xD;
         12. ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivia Sgarbura</last_name>
    <role>Study Chair</role>
    <affiliation>Institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut réginal du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</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>Carcinoma</mesh_term>
    <mesh_term>Peritoneal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Oxycodone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03253133
org study id: ICM-URC2015/34
nct id: NCT03253133
lead sponsor: 
has dmc: No
This study determine the maximal tolerate dose
This study determine the maximal tolerate dose for the patient treated by intraperitoneal
      chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose
time frame: through study completion, an average of 3 year
description: To determine:
- Maximum tolerated dose (MTD),
measure: Area Under the Curve (AUC)
time frame: through study completion, an average of 3 year
description: To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue
arm group label: Oxaliplatin
arm group type: Experimental
description: IP neoadjuvant chemotherapy protocol:
Oxaliplatine will be administered in IP in a total solution of 2L of serum G5%. A continuous infusion pump of Oxycodone would be administered for the entire duration of the intraperitoneal chemotherapy. Perfusion time for the intraperitoneal chemotherapy is estimated but not limited to one and a half hour.
Intravenous chemotherapy protocol:
Associated Intravenous (systemic) chemotherapy is administered during IP chemotherapy including at least LVFU2 (5FU-Leucovorin) or FOLFIRI (5FU-Irinotecan) regimens and targeted therapy if needed.
intervention type: Drug
intervention name: Oxaliplatin
description: Dose levels of Oxaliplatin:
4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1
Table 1: Dose levels
Dose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 * 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6
* Start level
arm group label: Oxaliplatin
intervention type: Drug
intervention name: LV5FU or Folfiri
description: Association of chemotherapy by LV5FU or Folfiri according pratician choice
arm group label: Oxaliplatin
intervention type: Drug
intervention name: Oxycodone
description: Oxycodone
arm group label: Oxaliplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivia Sgarbura
role: Study Chair
affiliation: Institut régional du Cancer de Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Peritoneal Neoplasms
mesh term: Oxaliplatin
mesh term: Oxycodone
sharing ipd: No