safety and efficacy study of combination therapy with cetuximab and folfox4 in patients with colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine confirmed objective response rate to combination therapy with cetuximab and folfox4 or folfox4 alone in patients with crc and non-resectable hepatic metastases


Eligibility criteria:
inclusion criteria: * written informed consent. * men and women \< 75 years * histologically confirmed diagnosis of crc * metastatic colorectal carcinoma with exclusive non-resectable hepatic metastases, due to fulfillment of one of the following criteria: 1. number of hepatic metastases \> or= 4; 2. size of one or more hepatic metastases \> 5 cm diameter; 3. vascular involvement and/or poor site that prevent complete resection of hepatic disease and/or require resection with the remaining liver mass less than 25-30% of functional liver. * presence of at least one lesion detectable by two-dimensional measurement. * karnofsky functional status \>or=70% at the time of enrollment in study * life expectancy greater than 3 months. * patients must not have received chemotherapy for advanced/metastatic disease. * patients with the following characteristics will be enrolled: 1. recurrence after adjuvant treatment with 5-fluorouracil/folinic acid or capecitabine +/- radiotherapy with disease-free period \> 6 months following conclusion of treatment. 2. recurrence after surgical and/or radiotherapy treatment without adjuvant systemic treatment. 3. de novo diagnosis of disease. * proper liver function, defined by aspartate aminotransferase (ast/sgot) and alanine aminotransferase (alt/sgpt) \< or = 2.5 x uln (\< or = 5 x uln if there are hepatic metastases) and total bilirubin count \< 1.5 x uln. * proper kidney function, defined as serum creatinine \< 1.5 x uln. * proper hematological function, defined as neutrophil count \> or = 1.5 x 109/l , platelets \> or = 100 x 109/l and hemoglobin \> or = 9 g/dl. * effective birth control method for men as well as women if there is possibility of pregnancy exclusion criteria: * documented or suspected cerebral and/or leptomeningeal metastases. * metastasis in any other non-hepatic site, including extrahepatic lymph node metastases. * surgery (excluding biopsy for diagnosis) and/or radiotherapy within 4 weeks prior to enrollment in the study. * participation in another clinical trial with medication in the past 30 days. * chronic, concomitant administration of systemic immunotherapy, chemotherapy, hormone therapy or any other investigational drug. * prior malignant tumour in past 5 years, except history of basal cell skin carcinoma or pre-invasive cervical carcinoma. * any investigational drug during the 4 weeks prior to enrolment. * prior administration of monoclonal antibodies, egfr signal transduction inhibitors or egfr-targeted treatment. * prior participation in study in which treatment with cetuximab can be assigned (whether or not treatment with cetuximab is received) * acute or subacute intestinal occlusion or history of inflammatory intestinal disease. * evidence of grade 3 or 4 allergic reaction to any of the treatment components. * clinically relevant peripheral neuropathy. * clinically relevant myocardial disease or history of myocardial infarction in the past 12 months. * known abuse of alcohol / drugs, legal incapacity or limited legal capacity. * any medical or psychological disorder which, in the opinion of the investigator, does not allow the patient to conclude the study or sign the informed consent. * pregnant or nursing woman

Keywords: colorectal cancer cetuximab folfox4