Cancer of Head and Neck Clinical Trial
Official title:
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
The purpose of this study is to evaluate the response of the tumor to the treatment regimen
that will be used in this study. This study will also test the safety of cetuximab (C225),
given with chemotherapy and radiation therapy. We also want to see what effects (good and
bad) cetuximab, chemotherapy, and radiation therapy have head & neck cancer.
C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways
that lead to tumor cell growth. In prior studies with head & neck cancer patients, C225 has
delayed tumor growth and provided relief of symptoms in some patients.
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
weeks 2-9)
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
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