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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01082315
First received: March 3, 2010
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Colorectal Neoplasms
Drug: Erbitux (Cetuximab)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Korean Post-Marketing Surveillance Study On Erbitux® (Cetuximab) in Patients With EGFR-expressing, KRAS Wild-type Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Safety [ Time Frame: Initial treatment period to final treatment period ] [ Designated as safety issue: Yes ]
    Incidence and severity of all adverse events, regardless of the causal relationship to Erbitux


Secondary Outcome Measures:
  • Clinical efficacy [ Time Frame: The evaluation date to show best tumour response during the treatment of Erbitux ] [ Designated as safety issue: No ]
    Best tumour response, time to progression of tumour and duration of response with Erbitux treatment; liver metastasis resectability.


Enrollment: 730
Study Start Date: April 2009
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Erbitux
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with EGFR-expressing, KRAS wild-type mCRC undergoing treatment with Erbitux in Korea.

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082315

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Merck KGaA
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01082315     History of Changes
Other Study ID Numbers: EMR 62202-509 (EMR 62202-551)
Study First Received: March 3, 2010
Last Updated: August 28, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Merck KGaA:
Colorectal cancer
Neoplasm metastasis
Cetuximab
Erbitux
EGFR

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014