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

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Colorectal Neoplasm

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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.


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.

Inclusion Criteria:

- Subjects who are eligible for Erbitux treatment according to the indication in the
national label of Erbitux (i.e. in EGFR expressing, KRAS wild-type metastatic
colorectal adenocarcinoma).

- Subjects who have failed oxaliplatin and irinotecan-based therapy and who are
intolerant to irinotecan in mCRC.

- Subjects who have signed the informed consent form

Exclusion Criteria:

- Subjects who do not fall under the approved indications according to the national
label of Erbitux.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Safety and toxicity of Erbitux treatment

Outcome Description:

Frequency and severity of all AEs and serious adverse events; Laboratory information (haematology, clinical chemistry, EGFR test and KRAS test).

Outcome Time Frame:

120 minutes and for the subsequent weekly doses is 60 minutes. Before, during and at the end of Erbitux treatment period

Safety Issue:


Principal Investigator

Tae-Won Kim, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center, Seoul, Korea, Republic of


Korea: Food and Drug Administration

Study ID:

EMR 62202-507



Start Date:

September 2008

Completion Date:

January 2012

Related Keywords:

  • Colorectal Neoplasm
  • Colorectal cancer
  • Metastasis
  • Cetuximab
  • Erbitux
  • Epidermal growth factor receptor
  • Neoplasms
  • Colorectal Neoplasms