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.
Study Type
OBSERVATIONAL
Enrollment
133
The starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min.
Ambaa Hospitals
Hyderabad, Andhra Pradesh, India
Indo- American Cancer Institute & Research Centre
Hyderabad, Andhra Pradesh, India
NVS Ramakrishna's Clinic
Hyderabad, Andhra Pradesh, India
Dr. Nikhil's Clinic
Secunderabad, Andhra Pradesh, India
Swarna Sai Hospital
Secunderabad, Andhra Pradesh, India
Sparsh Hospital
Orissa, Bhubaneswar, India
Wellness Consultants Clinic
Surat, Gujarat, India
Global Health Pvt Ltd
Gurgaon, Haryana, India
The Cancer Clinic
Kochi, Kerala, India
Dr. T. P. Sahoo's Clinic
Bhopal, Madhya Pradesh, India
...and 18 more locations
To obtain further safety information on the use of Cetuximab in combination with platinum-based chemotherapy in patients with recurrent/metastatic SCCHN.
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)
Time frame: From first infusion of cetuximab until 28 days after the last infusion.
To obtain clinical effectiveness information of Cetuximab in combination with platinum based chemotherapy in patients with recurrent/ metastatic SCCHN.
Clinical efficacy will be assessed by best tumor response, disease control rate, progression-free survival and overall survival with cetuximab treatment.
Time frame: From first infusion of cetuximab until 28 days after the last infusion.
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