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Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC (NIPOX)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Oxaliplatin
LV5FU or Folfiri
Oxycodone
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged over 18 years old
  2. Histologically confirmed diagnosis of colorectal or appendix cancer
  3. Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery
  4. Peritoneal Carcinomatosis Index > 17
  5. Previous adjuvant chemotherapy is allowed
  6. One or several lines of chemotherapy are allowed
  7. Hemoglobin ≥ 10 g/dL (red blood transfusion is allowed if needed), neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3 and white blood cells > 3000 /mm3
  8. Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN
  9. Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN
  10. ECOG (Eastern Cooperative Oncology group) < 1
  11. Life expectancy higher than 8 weeks
  12. Negative pregnancy test in women of childbearing potential
  13. Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment
  14. Patients affiliated to a French Social Security System
  15. Signed informed consent (IC) obtained before any study specific procedures

Exclusion Criteria:

  1. Serum uracile ≥ 16 ng/ml
  2. Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes)
  3. Patients with anesthetic or medical contraindications to surgery
  4. Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF
  5. Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months.
  6. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion
  7. History or presence of other cancer within the past 5 years (except adequately treated in situ carcinoma of the cervix and non-melanoma skin cancer)
  8. Pregnant or breastfeeding women
  9. Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections
  10. Participation in another clinical trial within 30 days prior to study entry
  11. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study
  12. ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women

Sites / Locations

  • Institut réginal du Cancer de Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxaliplatin

Arm 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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose
To determine: - Maximum tolerated dose (MTD),

Secondary Outcome Measures

Area Under the Curve (AUC)
To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue

Full Information

First Posted
August 29, 2016
Last Updated
May 2, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT03253133
Brief Title
Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC
Acronym
NIPOX
Official Title
Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2016 (Actual)
Primary Completion Date
October 28, 2020 (Actual)
Study Completion Date
April 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study determine the maximal tolerate dose
Detailed Description
This study determine the maximal tolerate dose for the patient treated by intraperitoneal chemotherapy in neoadjuvant treatment of peritoneal carcinomatosis of colorectal origin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxaliplatin
Arm Type
Experimental
Arm 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(s)
Oxaliplatin
Intervention 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
Intervention Type
Drug
Intervention Name(s)
LV5FU or Folfiri
Intervention Description
Association of chemotherapy by LV5FU or Folfiri according pratician choice
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Oxycodone
Primary Outcome Measure Information:
Title
Maximum tolerated dose
Description
To determine: - Maximum tolerated dose (MTD),
Time Frame
through study completion, an average of 3 year
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC)
Description
To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue
Time Frame
through study completion, an average of 3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged over 18 years old Histologically confirmed diagnosis of colorectal or appendix cancer Peritoneal carcinomatosis of colorectal origin, presumed unresecable or non-optimally resecable, assessed by imaging (CT scan (Computed Tomography Scanner) and MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery Peritoneal Carcinomatosis Index > 17 Previous adjuvant chemotherapy is allowed One or several lines of chemotherapy are allowed Hemoglobin ≥ 10 g/dL (red blood transfusion is allowed if needed), neutrophils ≥ 1.500/mm3, platelets ≥ 100.000/mm3 and white blood cells > 3000 /mm3 Total bilirubin ≤ 1.5 Upper limit of normal (ULN), ALT or AST ≤ 3 ULN Serum creatinine ≤ 1.5 ULN ; Serum calcium ≥ LLN and ≤ 1.2 x UNL ; Serum magnesium ≥ LLN and ≤ 1.2 x UNL ; Kalemia ≥ LLN ECOG (Eastern Cooperative Oncology group) < 1 Life expectancy higher than 8 weeks Negative pregnancy test in women of childbearing potential Use of an effective contraceptive method during the whole treatment and up to 6 months after the completion of treatment Patients affiliated to a French Social Security System Signed informed consent (IC) obtained before any study specific procedures Exclusion Criteria: Serum uracile ≥ 16 ng/ml Extra peritoneal metastatic disease (except ovarian metastases and retroperitoneal nodes) Patients with anesthetic or medical contraindications to surgery Peripheral sensory neuropathy ≥ grade 2 at the time of signing the ICF Patients previously treated with cytoreduction and followed by an intra-peritoneal chemotherapy within the past 6 months. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion History or presence of other cancer within the past 5 years (except adequately treated in situ carcinoma of the cervix and non-melanoma skin cancer) Pregnant or breastfeeding women Known positive test for human immunodeficiency virus (HIV), hepatitis B or C virus or patients with untreated serious infections Participation in another clinical trial within 30 days prior to study entry Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study ECG with a QT/QTc interval higher than 450 ms for men and higher than 470 ms for women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia Sgarbura
Organizational Affiliation
Institut régional du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut réginal du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

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