Inclusion 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