An Observational Study of Erbitux® in Patients With Metastatic Colorectal Cancer (mCRC) Refractory to Irinotecan-containing Treatment

NCT01074333 | Terminated

• 1 other identifier: EMR 62202-507
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Neoplasm

Keywords

Colorectal cancer; Metastasis; Cetuximab; Erbitux; Epidermal growth factor receptor

Outcome Measures

Primary Outcomes (1)

• Safety and toxicity of Erbitux treatment

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

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

Secondary Outcomes (1)

• Clinical efficacy of Erbitux treatment

  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

Interventions

Cetuximab DRUG

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. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered 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.

Also known as: Erbitux

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Ltd.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tae-Won Kim, M.D., Ph.D.

  Asan Medical Center, Seoul, Korea, Republic of

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: June 17, 2014

Record last verified: 2014-06

Locations

KR (1)