Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients (CIFRA)
Colorectal Cancer, ADCC
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Cytological or histological diagnosis of colorectal adenocarcinoma;
- KRAS, NRAS, BRAF wild-type;
- FcγRIIIaV/V genotype;
- stage IV;
- age <75 years;
- at least 1 measurable lesion;
- ECOG (Eastern Cooperative Oncology Group) Performance Status 0 or 1;
- life expectancy> 3 months;
- negative pregnancy test for all potentially childbearing women;
- written informed consent.
Exclusion Criteria:
- previous systemic anti-tumor treatment (allowed treatment with capecitabine or fluorouracil and radiotherapy in the neoadjuvant setting of rectal tumors with therapy terminated at least 6 months before);
- presence of primary non-treated stenosing colorectal neoplasm;
- neutrophils <2000/mm³ or platelets <100.000/mm³ or hemoglobin <9 g/dl;
- serum creatinine level> 1.5 times the maximum normal value;
- GOT (glutamic oxaloacetic transaminase) and/or GPT (glutamic pyruvic transaminase) >5 times the maximum normal value and/or bilirubin level >3 times the maximum normal value;
- previous malignant neoplasms (excluding basal or spinocellular cutaneous carcinoma or in situ carcinoma of the uterine cervix);
- active or uncontrolled infections;
- other concomitant uncontrolled diseases or conditions contraindicating the study - drugs at clinician evaluation;
- presence of brain metastases;
- refusal or inability to provide informed consent;
- impossibility to guarantee follow-up.
Sites / Locations
- Istituto Nazionale dei Tumori,Recruiting
Arms of the Study
Arm 1
Experimental
Folfiri/Cetuximab
Cetuximab 400 mg/mq intravenously (iv) with "load" dose of 400 mg/mq at the first cycle followed by 250 mg/mq iv weekly by iv infusion in 90 minutes. The administration of irinotecan will precede that of cetuximab and will consist on a dose of 180 mg/mq iv in 60 minutes every two weeks and it will be followed by fluorouracil (5-FU) at a dose of 400 mg/mq in slow iv bolus at half of lederfolin 200 mg/mq 2-hours infusion. At the end of the infusion of lederfolin an elastomeric pump loaded with 5-FU 2400 mg/mq in continuous 46 hours iv infusion will be applied. Only at the first administration of CT ("load" dose of cetuximab), irinotecan will not be administered.