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

Phase I Study Assessing Safety of Intraperitoneal Chemotherapy in Neoadjuvant Treatment of Peritoneal Carcinomatosis of Colorectal Origin

This study determine the maximal tolerate dose

Study Overview

Status

Completed

Conditions

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

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Montpellier, France, 34298
        • Institut réginal du Cancer de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxaliplatin

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.

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

Association of chemotherapy by LV5FU or Folfiri according pratician choice
Oxycodone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose
Time Frame: through study completion, an average of 3 year

To determine:

- Maximum tolerated dose (MTD),

through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC)
Time Frame: through study completion, an average of 3 year
To evaluate Long term pharmacokinetic profile of associated targeted agents in tumoral tissue
through study completion, an average of 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Olivia Sgarbura, Institut Regional Du Cancer de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2016

Primary Completion (Actual)

October 28, 2020

Study Completion (Actual)

April 24, 2023

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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