Erbitux MEtastatic Colorectal Cancer Strategy Study

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

• To investigate whether cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free Survival when compared with continuous FOLFIRI + cetuximab (given until progression or cumulative toxicity).

• To assess whether an improvement in the incidence of grade 3-4 hematological and non-hematological adverse events (AEs) can be achieved in the experimental arm (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous chemotherapy arm (FOLFIRI plus cetuximab)

• To explore the possibility of using liquid biopsies for molecular profiling as well as monitoring treatment activity in mCRC pts receiving cetuximab based therapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armando Orlandi; Carlo Barone
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Histologically proven diagnosis of colorectal adenocarcinoma

• Diagnosis of metastatic disease

• RAS and BRAF wildtype

• Measurable disease according to RECIST criteria v1.1

• Male or female over 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

• Signed informed consent obtained at screening

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