A Phase II Study of Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck
Primary Objective- To evaluate whether the addition of Cetuximab (C225) in combination with
chemotherapy and radiation can cause an enhanced anti-tumor effect resulting in improving
local regional control of patients with locally advanced, unresectable squamous cell
carcinoma of head and neck. (SCCHN).
OVERVIEW OF STUDY DESIGN Open label, non-randomized, single arm trial.
P = Paclitaxel will be administered on a weekly schedule at a dose of 40mg/m2 IV by 1-hour
infusion prior to cetuximab dose. This will be administered for a total of 8 weeks (from
C225 = Cetuximab: 400 mg/m2 IV will be given as the initial OR loading dose in week 1 and
then 250 mg/m2 IV weekly will be given for 8 weeks (weeks 2-9).
C = Carboplatin will be given at a dose of AUC=2/week - will be administered as a 30 minute
infusion after cetuximab infusion (weeks 2-9)
RT = Radiation therapy will be delivered at 1.8 Gy fraction/day, 5 days a week for a total
of 70.2 Gy. RT will be given from weeks 2-9.
Note: Sequence of administration will be paclitaxel followed by cetuximab followed by
carboplatin followed by XRT.
Approximately 60 patients from MSGCC/BVAMC will participate in this study. Prior to entering
the study the doctor will examine the patient and order blood tests ( which will be done by
blood draw, approximately 2 tablespoons) and tests to measure the patients disease (scans).
The patient will also be evaluated by a dietician who will follow the patient throughout the
course of the therapy to help the patient meet his/her nutritional needs
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is the local regional control rate assessed 3 months post completion of radiation therapy
Mohan Suntharalingam, M.D
University of Maryland
United States: Food and Drug Administration
|University of Maryland & Baltimore VA medical centre||Baltimore, Maryland 21201|