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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

215 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Carcinoma, Squamous Cell of Head and Neck

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-Interventional Study

No Intervention

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Other Intervention Names

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Erbitux®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No