study evaluating the safety and efficacy of folfiri plus cetuximab or folfox plus cetuximab as first-line therapy in subjects with kras wild-type metastatic colorectal cancer (apec-study)

Conditions: Metastatic Colorectal Cancer

Summary: this is an open-label, non-randomized, multicenter phase ii study evaluating folinic acid + fluorouracil + irinotecan (folfiri) plus cetuximab (erbitux) or folinic acid + fluorouracil + oxaliplatin (folfox) plus cetuximab as first-line therapy of patients with kras wild-type metastatic colorectal cancer. only subjects with k-ras oncogene (kras) wild-type tumors are eligible. efficacy will be assessed every 8 weeks. treatment will be continued until progressive disease or unacceptable adverse events occur. after the end of study treatment, information on further anticancer treatment and survival will be collected every 3 months.


Eligibility criteria:
inclusion criteria: signed written informed consent * inpatient or outpatient subjects, 18 years of age * diagnosis of histologically confirmed adenocarcinoma of the colon or rectum * metastatic disease (m1) * life expectancy of at least 12 weeks * presence of at least 1 measurable index lesion (not lie in an irradiated area) by computed tomography (ct) scan or magnetic resonance imaging (mri) * eastern cooperative oncology group (ecog) performance status of 0 or 1 at study entry * effective contraception for both male and female subjects if the risk of conception exists * white blood cell count greater than or equal to (\>=) 3,000 per cubic millimeter (/mm\^3) with neutrophils \>=1,500/mm3, platelet count \>=100,000/mm3, hemoglobin \>=5.6 millimole per liter (mmol/l) (9 gram per deciliter \[g/dl\]) * total bilirubin less than or equal to (\<=) 1.5 x upper reference range * aspartate aminotransferase (ast) \<=2.5 x upper reference range, or \<=5 x upper reference range in case of liver metastasis * serum creatinine \<=1.5 x upper reference range * recovery from relevant toxicity to previous treatment before study entry * kras wild-type status of tumor tissue exclusion criteria: * previous chemotherapy for colorectal cancer except adjuvant treatment if terminated \>6 months before the start of treatment in this study * radiotherapy, surgery (excluding prior diagnostic biopsy) or any investigational drug in the 30 days before the start of treatment in this study * concurrent chronic systemic immune therapy, targeted therapy, anti-vascular endothelial growth factor (vegf) therapy, or epidermal growth factor receptor (egfr-) pathway targeting therapy not indicated in this study protocol * concurrent hormone therapy not indicated in this study protocol except for physiologic replacement or contraception * known hypersensitivity reaction to any of the components of study treatments * pregnancy (absence to be confirmed by beta human choriongonadotrophin \[beta-hcg\] test) or lactation period * brain metastasis and/or leptomeningeal disease (known or suspected) * clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia * acute or sub-acute intestinal occlusion or history of inflammatory bowel disease * peripheral neuropathy \> grade 1 * previous malignancy other than colorectal cancer in the last 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix * known alcohol or drug abuse * medical or psychological conditions that would not permit the patient to complete the study or sign informed consent * participation in another clinical study within the past 30 days * significant disease which, in the investigator's opinion, would exclude the patient from the study * legal incapacity or limited legal capacity * kras mutated status of tumor tissue

Keywords: mcrc