The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy. Primary end-point: incidence of complete macroscopic resections of liver metastases (R0+R1).
Conditions
Interventions
Trade Name: Erbitux
Product Name: CETUXIMAB (Erbitux)
Pharmaceutical Form: Solution for infusion
Sponsors
ARTBC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of liver metastases (new confirmation of metastatic disease is required in case the time interval from last histological diagnosis to enrolment exceeds 3 years). •Patients with at least one of the following criteria: ?less than 30% estimated residual liver after resection, ?more than 3 liver metastases, ?documented progressive disease on imaging documents or doubling of serum levels of carcino-embryonic antigen (CEA) or CA19.9 over the past 90 days or less. ?disease in contact with liver main vessels. •Patient whose liver metastases are considered to be non resectable with curative intent in medico-surgical staff meeting •One, two or three prior chemotherapy lines for colorectal cancer. •Written informed consent. •Age ³18 years. •Patient must be able to comply with the protocol. •Life expectancy of at least 3 months. •At least one measurable metastatic liver lesion (as per RECIST criteria). •World Health Organization performance status of 0 or 1. •Adequate hematological function: absolute neutrophil count (ANC) ³1.0 x 109/L; platelets ³75 x 109/L, hemoglobin (Hb) ³8.5 g/dL. •International normalized ratio (INR) £1.5 and activated partial thromboplastin time (aPTT) £1.5 x upper limit of normal (ULN) within 7 days prior to starting study treatment, in the absence of anticoagulant therapy. •Liver function: serum bilirubin £1.5 x ULN; alkaline phosphatase and transaminases =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Extrahepatic disease, whether resectable or not. •Prior HAI of the 3 drugs. •More than 2 prior surgical attempts for metastatic disease •Prior radiotherapy for metastatic disease •Known documented intolerance or hypersensitivity to any of the drugs used. •Sensory neuropathy grade 3 (National Cancer Institute-Common Terminology Criteria for Adverse Events -NCI-CTCAE, Version 3.0). •Past or current history (within the last 2 years prior to treatment start) of malignancy other than colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible). •Serious, non healing wound, ulcer, or bone fracture. •Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications. •Pregnancy or lactation •Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to increase by 15% the complete macroscopic resection rate of predominantly liver metastases from metastatic colorectal cancer through combining systemic cetuximab and hepatic artery infusion of three-drug chemotherapy. Primary end-point: incidence of complete macroscopic resections of liver metastases (R0+R1). ;Secondary Objective: Secondary end-points: •the rate of histologic complete responses, •the individual rates of R0 and R1 resections, •the rate and site(s) of relapse in the resected patients throughout the 3-year span that follows hepatectomy,, •the relapse-free survival curve and median in the resected patients, •the progression-free and the overall survival in the patients receiving at least 4 full courses of HAI therapy and in all the patients (intent to treat), •the objective response rate, •the rate of adverse events, •the dose intensities over 3, 6 and 9 courses, •the per-operative and post-operative complications associated to liver surgery. ;Primary end point(s): Primary end-point: incidence of complete macroscopic resections of liver metastases (R0+R1). | — |
Countries
France, Portugal
Outcome results
None listed