Clinical trial NCT01074333: An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment
Official title: Prospective, Multicenter, Observational Study on Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Neoplasm
Keywords: Colorectal cancer
Metastasis
Cetuximab
Erbitux
Epidermal growth factor receptor
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Ltd.
First posted: 2010-02-24
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with EGFR-expressing, KRAS wild-type mCRC undergoing treatment with Erbitux in Korea.

Brief summary: This is an observational, non-interventional, uncontrolled, multicentric safety study in subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type mCRC. The study aims to collect safety data related to Erbitux treatment from a total of at least 400 mCRC subjects from about 35 institutions from the start of treatment with Erbitux until progressive disease, Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever occurs first).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety and toxicity of Erbitux treatment
timeFrame: 120 minutes and for the subsequent weekly doses is 60 minutes. Before, during and at the end of Erbitux treatment period
Secondary outcomes:
measure: Clinical efficacy of Erbitux treatment
timeFrame: 120 minutes and for the subsequent weekly doses is 60 minutes From the start of treatment with Erbitux until progressive disease, Erbitux related intolerable toxicities, death, or withdrawal of Erbitux treatment whichever occurs first
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center, Seoul, Korea, Republic of
name: Tae-Won Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: