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.