NCT03253133

Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Oxaliplatin	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
DRUG	LV5FU or Folfiri	Association of chemotherapy by LV5FU or Folfiri according pratician choice
DRUG	Oxycodone	Oxycodone

Timeline

• Start date: 2016-05-10
• Primary completion: 2020-10-28
• Completion: 2023-04-24
• First posted: 2017-08-17
• Last updated: 2023-05-03

Locations

1 site across 1 country: France