Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

Phase 1

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Oxaliplatin; Drug: LV5FU or Folfiri; Drug: Oxycodone

• Registration Number: NCT03253133
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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

Study Timeline

• Study Start: 2016-05-10
• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Primary Completion: 2020-10-28
• Study Completion: 2023-04-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxaliplatin	LV5FU or Folfiri	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.
Oxaliplatin	Oxycodone	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.
Oxaliplatin	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.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	through study completion, an average of 3 year	To determine: - Maximum tolerated dose (MTD),

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut réginal du Cancer de Montpellier; 🇫🇷 Montpellier, France