evaluation of the standard therapy with FOLFIRI+CEtuximab until disease progression compared to FOLFIRI+Cetuximab for 8 cycles followed by Cetuximab until disease progression in first line treatment of patients with RAS and BRAF wild type metastic colorectal cancer

Phase 1

• Conditions: Patients with unresectable, KRAS, NRAS and BRAF wild-type (WT) metastatic colorectal cancer.; MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-004299-41-ES
• Lead Sponsor: Dipartimento di Scienze mediche Oncologia Medica Policlinico Gemelli

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

•Histologically proven diagnosis of colorectal adenocarcinoma
•Diagnosis of metastatic disease
•Hepatic metastases which are deemed to be amenable for surgical resection, but for which the pharmacological treatment could be considered useful before proceeding to the intervention, upon clinical judgment.
•RAS and BRAF wild-type
•Measurable disease according to RECIST criteria v1.1
•Male or female pts > 18 years of age
•ECOG Performance Status = 2
•Life expectancy of at least 3 months
•Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment
•If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment
•If female and of childbearing potential, or if male, agreement to use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double-barrier method).
•Signed informed consent obtained at screening
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

•Any contraindication to use cetuximab, irinotecan, 5-FU or folinic acid
•Active uncontrolled infections or active disseminated intravascular coagulation
•Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix
•Pregnancy.
•Breastfeeding.
•Grade III or IV heart failure (NYHA classification)
•Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study
•Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin
•Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
•Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
•Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study
•Known or clinically suspected brain metastases
•History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea
•Severe, non-healing wounds, ulcers or bone fractures
•Uncontrolled hypertension
•Marked proteinuria (nephrotic syndrome)
•Known DPD deficiency (specific screening not required)
•Known history of alcohol or drug abuse
•A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
•Absent or restricted legal capacity

Study & Design

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