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

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ClinicalTrials.gov Identifier: NCT01080066
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
Choice Pharma Taiwan
Information provided by (Responsible Party):
Merck KGaA

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.

Condition or disease Intervention/treatment
Carcinoma, Squamous Cell of Head and Neck Other: No Intervention

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


Study Type : Observational
Actual Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
Study Start Date : September 2010
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Non-Interventional Study 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®



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Time to progression [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ]
  3. Duration of response [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ]
  4. Overall Survival [ Time Frame: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with SCCHN and are eligible to receive cetuximab and radiotherapy according to the local label
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080066


Locations
Taiwan
Liouying Chi-Mei Hospital
Liouying, Tainan County, Taiwan
Sponsors and Collaborators
Merck KGaA
Choice Pharma Taiwan
Investigators
Principal Investigator: Chao-Jung Tsao, Dr. Liouying Chi-Mei Hospital

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080066     History of Changes
Other Study ID Numbers: EMR62202-512
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Merck KGaA:
Carcinoma
Squamous cell
Erbitux
cetuximab
Head
Neck

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents