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

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080066
• Other study ID #: EMR62202-512
• Status: Completed
• Phase: N/A
• First received: February 18, 2010
• Last updated: July 7, 2014
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Head and Neck Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Taiwan	Liouying Chi-Mei Hospital	Liouying	Tainan County

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Choice Pharma Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse drug reactions and serious adverse drug reactions		From the first infusion of cetuximab until three months after the last infusion of Cetuximab	Yes
Primary	Number of subjects discontinuing the study due to intolerability of cetuximab		From the first infusion of cetuximab until three months after the last infusion of Cetuximab	Yes
Secondary	Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable		From the first infusion of cetuximab until three months after the last infusion of cetuximab	No
Secondary	Time to progression		From the first infusion of cetuximab until three months after the last infusion of cetuximab	No
Secondary	Duration of response		From the first infusion of cetuximab until three months after the last infusion of cetuximab	No
Secondary	Overall Survival		From the first infusion of cetuximab to death until three months after the last infusion of cetuximab	No