Clinical trial NCT01080066: A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Official title: A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Squamous Cell of Head and Neck
Keywords: Carcinoma
Squamous cell
Erbitux
cetuximab
Head
Neck
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Choice Pharma Taiwan
First posted: 2010-03-03
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with SCCHN and are eligible to receive cetuximab and radiotherapy according to the local label

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of adverse drug reactions and serious adverse drug reactions
timeFrame: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
measure: Number of subjects discontinuing the study due to intolerability of cetuximab
timeFrame: From the first infusion of cetuximab until three months after the last infusion of Cetuximab
Secondary outcomes:
measure: Number of subjects with best tumor response categories that are, complete response, partial response, stable disease, progressive disease and not evaluable
timeFrame: From the first infusion of cetuximab until three months after the last infusion of cetuximab
measure: Time to progression
timeFrame: From the first infusion of cetuximab until three months after the last infusion of cetuximab
measure: Duration of response
timeFrame: From the first infusion of cetuximab until three months after the last infusion of cetuximab
measure: Overall Survival
timeFrame: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab
Other outcomes:
Locations:
city: Liouying
country: Taiwan
facility: Liouying Chi-Mei Hospital
state: Tainan County
Study officials:
affiliation: Liouying Chi-Mei Hospital
name: Chao-Jung Tsao, Dr.
role: PRINCIPAL_INVESTIGATOR
References: