Patients with histologically documented metastatic wild- type CRC not suitable for curative-intent resection MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Trade Name: ERBITUX*INFUS 1FL 50ML 2MG/ML
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
REGIONE LOMBARDIA - DIREZIONE GENERALE SANITA`
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed written informed consent - Male or female  18 years of age - Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum - KRAS evaluation availability with wild-type result - Metastatic CRC not suitable for curative-intent resection - Availability of tumour samples (or able and willing to provide tumour sample) and blood for biological analysis - Presence of at least one lesion measurable unidimensionally by computed tomography (CT) scan or magnetic resonance imaging (MRI). (index lesion(s) must not lie within an irradiated area) - Eastern cooperative oncology group-performance status (ECOG-PS) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Brain metastasis (known or suspected) - Previous chemotherapy for metastatic CRC (any). Adjuvant therapy is allowed if the chemotherapy treatment free interval is > 6 months - Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry - Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol - Any investigational agent(s) within 4 weeks prior to entry - Previous exposure to HER-axis -pathway targeting therapy - Leucocytes 1.5 x ULN - ASAT and ALAT >2.5 x ULN (>5 x ULN if liver metastasis are present) - Serum creatinine >1.5 x ULN - Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months - Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease - Pre-existing neuropathy > grade 1 - Known grade 3 or 4 allergic reaction to any of the components of the treatment. - Any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for  5 years will be allowed to enter the trial) - Pregnancy or lactation - Inadequate contraception (male or female patients) if of childbearing or procreational potential - Known drug abuse/ alcohol abuse - Legal incapacity or limited legal capacity - Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy in terms of PFS of the addition of cetuximab to FOLFIRI vs. FOLFIRI alone given as first line therapy in patients with advanced CRC. In particular, the predictive value of PTEN mutation will be assessed in determining the effect of cetuximab+FOLFIRI as compared to chemotherapy alone.;Secondary Objective: - Overall survival - Response rate - Quality of life - Safety profiles of the treatments - Economical evaluation;Primary end point(s): Progression free survival (PFS) | — |
Countries
Italy
Outcome results
None listed