study to evaluate the efficacy and safety of folfox-4 plus cetuximab versus ufox plus cetuximab.

Conditions: Previously Untreated Metastatic Colorectal Cancer

Summary: this is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with ufox (a combination regimen of uft® (tegafur plus uracil), oxaliplatin, folinic acid) plus cetuximab or folfox-4 (a combination regimen of 5 fluorouracil (5-fu), oxaliplatin and folinic acid) plus cetuximab)


Eligibility criteria:
inclusion criteria * signed written informed consent * inpatient or outpatient ≥ 18 years of age * diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * first occurrence of metastatic disease (not curatively resectable) * presence of at least one lesion measurable uni dimensionally by computerised tomography (ct) scan or magnetic resonance imaging (mri). (target lesion(s) must not lie within an irradiated area) * life expectancy of ≥ 3 months * karnofsky performance status of ≥ 60, at study entry * white blood cell count (wbc) ≥ 3 x 10\^9/l, with neutrophils ≥ 1.5 x 10\^9/l, platelets ≥ 100 x 10\^9/l, and hemoglobin ≥ 9 g/dl * aspartate transaminase and alanine transaminase ≤ 2.5 x upper limit of normal (uln) (≤ 5 x uln if liver metastasis are present) * normal serum creatinine (in case of elevated creatinine, labelled ethylenediaminetetraacetic acid clearance ≥ 65 ml/min is acceptable) * effective contraception for both male and female subjects if the risk of conception exists * tumor biopsy or archived sample available exclusion criteria: * brain metastasis and/or leptomeningeal disease (known or suspected) * previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment. * previous oxaliplatin-based chemotherapy * surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization * concurrent or previous chronic systemic immune therapy, targeted therapy, anti-vascular epithelial growth factor (vegf) therapy, epidermal growth factor receptor (egfr) pathway targeting therapy not indicated in the study protocol * concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception * clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * peripheral neuropathy \>grade 1 * known hypersensitivity reaction to any of the components of the treatment. * any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix. (subjects with a previous malignancy but without evidence of disease for ≥ 5 years will be allowed to enter the study) * pregnancy (absence to be confirmed by ß-human chorionic gonadotrophin test) or lactation period * 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 subject to complete the study or sign meaningful informed consent * participation in another clinical study within the 30 days before randomization * significant disease which, in the investigator's opinion, would exclude the subject from the study

Keywords: cancer colorectal metastatic untreated