An Observational Study to Evaluate the Safety and Efficacy of Cetuximab in Combination With Platinum-based Chemotherapy, in the First-line Therapy of Recurrent/ Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Squamous Cell
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Enrollment
- 133
- Locations
- 28
- Primary Endpoint
- To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The aim of this prospective, observational, multicenter, post-marketing study is to evaluate the safety and efficacy of Cetuximab (Erbitux) in combination with platinum based chemotherapy, in the first line therapy of recurrent/ metastatic squamous cell carcinoma of head and neck (SCCHN). A total of 100 subjects with SCCHN will be recruited in 20 centres across India.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The study inclusion criteria is as per the label for patients with metastatic/recurrent SCCHN approved by India Health Authorities, i.e., "Cetuximab is indicated for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease."
- •For each platinum-based chemotherapy, the related product labels approved by India Health Authorities will also be followed strictly in terms of patient eligibility.
Exclusion Criteria
- •Patients with known severe (grade 3 or 4; National Cancer Institute-Common Toxicity Criteria \[NCI-CTC\]) hypersensitivity reactions to Cetuximab are contraindicated for Cetuximab
Outcomes
Primary Outcomes
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
Time Frame: From first infusion of cetuximab until 28 days after the last infusion.
Safety variables will include the assessment of incidence and type of adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), incidence of withdrawals due to intolerability of cetuximab and severity of adverse events (AEs)
Secondary Outcomes
- To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.(From first infusion of cetuximab until 28 days after the last infusion.)