A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

This study has been completed.
Sponsor:
Collaborator:
Choice Pharma Taiwan
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080066
First received: February 18, 2010
Last updated: July 7, 2014
Last verified: July 2014

February 18, 2010
July 7, 2014
September 2010
December 2013   (final data collection date for primary outcome measure)
  • Number of adverse drug reactions and serious adverse drug reactions [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of Cetuximab ] [ Designated as safety issue: Yes ]
  • Number of subjects discontinuing the study due to intolerability of cetuximab [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of Cetuximab ] [ Designated as safety issue: Yes ]
Safety parameters [ Time Frame: From the first infusion of Erbitux until 28 days after the last infusion of Erbitux ] [ Designated as safety issue: Yes ]
  • Incidence and type of ADRs
  • Incidence and type of SADRs
  • Incidence of withdrawals due to intolerability of Erbitux
  • Severity of adverse events
Complete list of historical versions of study NCT01080066 on ClinicalTrials.gov Archive Site
  • Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
Efficacy parameters [ Time Frame: From the first infusion of Erbitux until 28 days after the last infusion of Erbitux ] [ Designated as safety issue: No ]
  • Best tumor response
  • Time to progression
  • Duration of response
  • Overall Survival
Not Provided
Not Provided
 
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)

This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with cetuximab based on the locally approved label.

Cetuximab is an immunoglobulin G1 (IgG1) monoclonal antibody that enhances the effects of some common chemotherapy agents and radiotherapy and demonstrates minimal overlapping toxicities with these approaches. This prospective, observational, non-interventional and multi-centric post marketing surveillance study is being conducted to collect safety information from subjects with locally advanced or recurrent/metastatic SCCHN treated with cetuximab based on the locally approved label. Study plans to enroll 200 to 300 subjects, who are eligible for cetuximab treatment according to the indication in the approved label of cetuximab by Taiwan Health Authority. Data related to subjects' demographics, relevant tumor history, and laboratory information (hematology, biochemistry) will be captured and analyzed descriptively.

OBJECTIVES

Primary objective:

• To obtain safety information on the use of cetuximab in subjects with SCCHN according to the regulatory approved label and in a regular clinical setting

Secondary objectives:

• To gather clinical efficacy information of the treatment

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects with SCCHN and are eligible to receive cetuximab and radiotherapy according to the local label

Carcinoma, Squamous Cell of Head and Neck
Other: No Intervention
Subjects administered with Cetuximab, once weekly by intravenous infusion at a first dose of 400 milligram per square meter (mg/m^2) body surface area for 120 minutes infusion period and subsequently at a dose of 250 mg/m^2 for 60 minutes infusion period, will be observed. The maximum infusion rate must not exceed 10 milligram per minute (mg/min).
Other Name: Erbitux®
Non-Interventional Study
Intervention: Other: No Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
215
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN
  • Age greater than or equal to 18 years
  • Signed informed consent

Exclusion Criteria:

  • Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version 4.03) hypersensitivity reactions to Cetuximab
  • Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01080066
EMR62202-512
No
Merck KGaA
Merck KGaA
Choice Pharma Taiwan
Principal Investigator: Chao-Jung Tsao, Dr. Liouying Chi-Mei Hospital
Merck KGaA
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP