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

NCT01080066 | Completed

• 1 other identifier: EMR62202-512
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Keywords

Carcinoma; Squamous cell; Erbitux; cetuximab; Head; Neck

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (4)

• 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

• Time to progression

  From the first infusion of cetuximab until three months after the last infusion of cetuximab

• Duration of response

  From the first infusion of cetuximab until three months after the last infusion of cetuximab

• Overall Survival

  From the first infusion of cetuximab to death until three months after the last infusion of cetuximab

Study Arms (1)

Non-Interventional Study

Other: No Intervention

Interventions

No Intervention 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).

Also known as: Erbitux®

Non-Interventional Study

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Choice Pharma Taiwan: collaborator

Study Sites (1)

Liouying Chi-Mei Hospital

Liuying, Tainan County, Taiwan

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chao-Jung Tsao, Dr.

  Liouying Chi-Mei Hospital

  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 18, 2010
• First Posted: March 3, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 8, 2014

Record last verified: 2014-07

Locations

TW (1)