A Post Marketing Surveillance Study of Cetuximab in Patients With Squamous Cell Carcinoma of Head and Neck (SCCHN)
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Purpose
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 | Intervention |
|---|---|
|
Carcinoma, Squamous Cell of Head and Neck |
Other: No Intervention |
| Study Type: | Observational |
| Study Design: | 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) |
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: From the first infusion of cetuximab until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: From the first infusion of cetuximab to death until three months after the last infusion of cetuximab ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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®
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Subjects with SCCHN and are eligible to receive cetuximab and radiotherapy according to the local label
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
Contacts and Locations| Contact: Clinical & Scientific Affairs Manager | +886-2-2162 1111 ext 1581 |
| Taiwan | |
| Liouying Chi-Mei Hospital | Recruiting |
| Liouying, Tainan County, Taiwan | |
| Contact: Chao Jung Tsao, MD PhD +886 622 6999 drcjtsao@yahoo.com.tw | |
| Principal Investigator: | Chao-Jung Tsao, Dr. | Liouying Chi-Mei Hospital |
More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT01080066 History of Changes |
| Other Study ID Numbers: | EMR62202-512 |
| Study First Received: | February 18, 2010 |
| Last Updated: | March 28, 2013 |
| Health Authority: | Taiwan: Department of Health |
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013