Trial Information

Prospective, Multicenter, Observational Study on Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer

Colorectal cancer is the fourth commonest form of cancer worldwide and remains a leading
malignancy both in incidence and mortality. Erbitux is an immunoglobulin G1 monoclonal
antibody that specifically blocks ligand binding to the EGFR with high affinity, thereby
preventing downstream signal transduction and cellular responses. Erbitux enhances the
effects of some common chemotherapy agents and radiotherapy and demonstrates minimal
overlapping toxicities with these approaches. Erbitux in combination with other treatment
modalities, has also shown efficacy in the treatment of a number of solid tumors, including
mCRC, squamous cell carcinoma of the head and neck, and non-small cell lung cancer. Based on
several studies conducted in the past, Erbitux has been approved for the treatment of
subjects with EGFR-expressing, KRAS wild-type mCRC, as a single agent in subjects who have
failed oxaliplatin-and irinotecan-based therapy and who are intolerant to irinotecan or in
combination with chemotherapy. The most common Erbitux-related adverse events (AEs) are
related to skin, infusion, and hypersensitivity reactions. Other side effects with Erbitux
monotherapy include asthenia, dyspnoea, mucositis, nausea, pain, fever and headache.

OBJECTIVES

Primary objective:

- To obtain safety information on the use of Erbitux in subjects with EGFR-expressing,
KRAS wild-type mCRC in terms of frequency and severity of AEs

Secondary objective:

- To gather clinical efficacy information of the treatment

The study will primarily collect safety data related to Erbitux treatment along with the
clinical efficacy information from the start of treatment with Erbitux until progressive
disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment
whichever occurs first. All subjects will be enrolled in the order to visit the physician
after making contract and each subject will be observed for a period of 4 months in average.
Erbitux will be prescribed to mCRC subjects according to the approved national label as in
routine clinical practice under the supervision of an investigator experienced in the use of
antineoplastic medicinal products. Prior to the first infusion, subjects will receive
pre-medication with an antihistamine and a corticosteroid. The initial dose of Erbitux is
400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered
intravenously (i.v.) via in-line filtration with an infusion pump, gravity drip, or a
syringe pump. The recommended infusion period for the initial dose is 120 minutes and for
the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5
ml/min. The observational period of this study is defined as from the first infusion of
Erbitux until 28 days after the last infusion of Erbitux in each subject, regardless the
reason of discontinuation of Erbitux treatment.