Trial Information

Phase II Study of C225 in Combination With Cisplatin and Standard/Delayed Accelerated Hyperfractionated Radiation Therapy in Patients With Advanced Head & Neck Cancer

OBJECTIVES: I. Determine the response rate in patients with newly diagnosed or recurrent,
advanced stage III or IV squamous cell carcinoma of the head and neck treated with 6
infusions of cetuximab at loading/maintenance doses in combination with 2 infusions of
cisplatin concurrent with standard/delayed accelerated hyperfractionated radiotherapy
followed by 4 weeks of single agent cetuximab. II. Assess the safety profile of this
treatment regimen in this patient population. III. Evaluate time to disease progression and
survival in these patients treated with this regimen. IV. Assess the impact of this
treatment regimen on the quality of life of these patients.

OUTLINE: Patients receive a loading dose of cetuximab IV over 120 minutes on week 1 followed
by 5 weekly maintenance doses over 60 minutes on weeks 2-6. Patients receive cisplatin IV
over 30 minutes on weeks 1 and 4 beginning 1 hour after completion of cetuximab infusion.
Radiotherapy is administered once daily during weeks 1-4 and twice daily during weeks 5 and
6. Following the initial 6 weeks of treatment, patients receive additional cetuximab IV over
30 minutes weekly on weeks 7-10. Quality of life is assessed at baseline, within 4 weeks
after completion of all treatment, and at 3-4 months. Patients are followed at 4-6 weeks,
12-16 weeks, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months
for 2 years.

PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.