Pilot Study: Biomarker Directed Treatment in Metastatic Colorectal Cancer

Study start date: December 4, 2012

Inclusion Criteria: 1.1 Inclusion criteria for pre-screening phase: Untreated advanced metastatic colorectal cancer patients Adequate tissue to evaluate for genotyping (10 x 10µm thick formalin fixed paraffin embedded tissue sections and one corresponding HE stained slide or a FFPE tumor block) 1.2 Inclusion criteria for treatment phase: Patients must fulfill all criteria listed below prior to enrolment in the study: Untreated wild-type KRAS metastatic colorectal cancer Previous adjuvant therapy must have been completed > 6 months before therapy initiation on this study Age >18 years Measureable disease with CT or MRI ECOG performance status of 0-2 Adequate organ function Hematologic: Absolute neutrophil count > 1,500/µL Hemoglobin >9 mg/dl Platelet count >100,000 /µl Renal: Serum creatinine <1.5 x Upper limit of normal (UPN) or estimated clearance > 30 ml/min Hepatic: Serum bilirubin < 1.5 mg/dl Exclusion Criteria: Creatinine clearance below 30 ml/min Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent. Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina. Other known co-morbidity with the potential to dominate survival Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the applied drugs Pregnant or breast feeding women Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.