Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

NCT03253133 | Completed Phase 1

• 1 other identifier: ICM-URC2015/34
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study determine the maximal tolerate dose

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

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

  through study completion, an average of 3 year

Secondary Outcomes (1)

• Area Under the Curve (AUC)

  through study completion, an average of 3 year

Study Arms (1)

Oxaliplatin

EXPERIMENTAL

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.

Drug: Oxaliplatin; Drug: LV5FU or Folfiri; Drug: Oxycodone

Interventions

Oxaliplatin DRUG

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

Oxaliplatin

LV5FU or Folfiri DRUG

Association of chemotherapy by LV5FU or Folfiri according pratician choice

Oxaliplatin

Oxycodone DRUG

Oxycodone

Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut réginal du Cancer de Montpellier

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatin; Oxycodone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Olivia Sgarbura

  Institut régional du Cancer de Montpellier

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: August 17, 2017
• Study Start: May 10, 2016
• Primary Completion: October 28, 2020
• Study Completion: April 24, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)