A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment

Study Overview
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Brief Summary
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After consultation with the Korean Health Authorities, the two Post-Authorization Safety Studies EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) were combined within one study protocol EMR 062202-551. This Post-Marketing Surveillance Study (PMS) EMR 062202-551 is requested by the Korean Health Authorities to continue monitoring of Erbitux and provide further information about safety and toxicity in clinical practice in at least 900 patients during 6 years. All data points from the EMR 62202-509 (NCT01082315) and EMR 62241-508 (NCT01075828) remain unchanged in protocol EMR 062202-551. Therefore, the Sponsor has decided not to separately disclose the EMR 062202-551 study titled A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With Locally Advanced or Recurrent and/or Metastatic Squamous Cell Cancer of the Head and Neck (originally EMR 62241-508) and in Patients With EGFR-expressing, KRAS wild-type Metastatic Colorectal Cancer (originally EMR 62202-509) on clinicaltrials.gov.

Detailed Description
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This is a post marketing surveillance (PMS), prospective study to collect safety information from more than 600 subjects with epidermal growth factor receptor (EGFR)-expressing, V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type metastatic colorectal cancer (mCRC) treated with Erbitux as final evaluable cases. This PMS is requested by the Korean Regulatory Authorities because after removal of an orphan drug in Korea, there is a requirement to investigate more than 600 patients during six years, to continue monitoring and provide further information about safety and toxicity in clinical practice. This PMS study is planned to be conducted within 6 years from the removal date of orphan drug in approximately 50 institutions in Korea. OBJECTIVES The objective of the study is to analyse the safety and efficacy information on the use of Erbitux in the market and factors affecting its safety and efficacy. Primary objective: To obtain safety information on the use of Erbitux in subjects with mCRC in terms of frequency and severity of adverse events (AEs) Secondary objective: To gather clinical efficacy information of the treatment During the PMS period, each subject's background, medical history (surgery, radiotherapy), Erbitux treatment status, concurrent medication, response evaluation, status and reason of discontinuation, all AEs (regardless of the causal relationship to Erbitux), and abnormal results of laboratory tests will be collected from the start of treatment with Erbitux until progressive disease, Erbitux-related intolerable toxicities, death, or withdrawal of Erbitux treatment (whichever occurs first). The primary endpoint, the safety evaluation will be based on all cases treated with Erbitux having received at least one dose. However, for efficacy evaluation, 12 weeks of treatment have to be applied to each subject. 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 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 10 mg/min, equivalent to 5 ml/min of Erbitux 2 mg/ml.

Official Title
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A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Drug: Erbitux (Cetuximab)


Participation Criteria
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Eligibility Criteria
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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 mCRC subjects in combination with chemotherapy, or as a single agent in subjects who failed oxaliplatin and irinotecan based therapy and who are intolerant to irinotecan) Exclusion Criteria: Subjects who are not eligible for Erbitux treatment according to the indication in the national label of Erbitux
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Erbitux (Cetuximab)|In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. Cetuximab 2mg/ml will be administered intravenously via in-line filtration with an infusion pump, gravity drip or a syringe pump. For the initial dose, the recommended infusion period is 120 minutes and for the subsequent weekly doses, the recommended infusion period is 60 minutes.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Incidence and severity of all adverse events, regardless of the causal relationship to Erbitux | Initial treatment period to final treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy | Best tumour response, time to progression of tumour and duration of response with Erbitux treatment; liver metastasis resectability. | The evaluation date to show best tumour response during the treatment of Erbitux | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Neoplasm metastasis, Cetuximab, Erbitux, EGFR