Safety of Intraperitoneal (IP) OXAliplatin (OXA) in Association With Systemic FOLFIRIBevacizumab Chemotherapy in Patients With Peritoneal Carcinosis ( IPOXA )

Phase 1

• Conditions: Patients with peritoneal carcinosis of colorectal origin and uncertain resectability with an indication for systemic chemotherapy compatible with the FOLFIRI + bevacizumab combination.; MedDRA version: 19.1Level: LLTClassification code 10052171Term: Peritoneal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-002738-55-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-20
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• =18 years old and = 75 years old
• ECOG Performance Status (PS) 0-2
• Peritoneal carcinosis with locoregional extension or metastastic of colorectal origin
and uncertain resectability
• PCI > 20 and / or infiltration of the hepatic pedicle and / or necessary digestive tract
resections
• Systemic chemotherapy indication, compatible with the FOLFIRI + bevacizumab
combination
• Satisfactory haematological evaluation: PNN rate greater than 1500 / mm3, platelet
count greater than 100 G / l;
• Satisfactory renal and hepatic function : serum creatinine =1.5 times the normal
lower values or creatinine clearance =50 ml / min, bilirubin =1.25 times lower
normal values, AST / ALT =1.5 times the lower normal values (=5 times the lower
normal values for patients with liver metastases)
• No unstable conditions: myocardial infarction within 6 months prior to the start
of the study, congestive heart failure, unstable angina, active cardiomyopathy,
unstable rhythm disorder, uncontrolled hypertension, uncontrolled psychiatric
disorders, severe infection, peptic ulcer or any condition that could be aggravated
by treatment or limit compliance (investigator assessment);
• No limitation in the number of previous treatments;
• Patients may have received conventional cytotoxic chemotherapy , hormonal or immunological targeted biological agents. They should have recovered from previous grade =2 toxicities
• Written informed consent
• Known RAS status.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 47
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Extraperitoneal metastases for which the site or number preclude potentially curative surgery at any moment during the course of the disease
• Sign of bowel obstruction or lesions whose topography indicates a risk of intestinal
perforation or inflammatory bowel disease
• ECOG PS 3-4
• Contraindication to the placement of a intraperitoneal central line
• Contraindication specifically related to intraperitoneal administration of oxaliplatin
• known history of hypersensitivity to oxaliplatin or to the excipients
• peripheral sensory neuropathy grade =2
• Pregnant or lactating women
• Unable to give consent
• Patient under legal protection measures
• Refusal to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified