Trial Information

Phase II Study of Cetuximab Anti-Epidermal Growth Factor Receptor (EGFr) Antibody in Combination With Chemotherapy in Patients With Metastatic or Recurrent Squamous Cell Head and Neck Carcinoma

OBJECTIVES: I. Determine the response rate, duration of response, and survival in patients
with metastatic or recurrent squamous cell carcinoma of the head and neck treated with
cetuximab and cisplatin after failure of an initial cisplatin-based chemotherapy regimen.
II. Determine the efficacy, safety, and toxicity of this regimen in these patients. III.
Assess the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study. Part I (courses 1 and 2): Patients are assigned to 1
of 2 treatment groups based on prior cisplatin-based chemotherapy regimen: Group 1 (prior
cisplatin with paclitaxel): Patients receive cisplatin IV over 1 hour on day 1 and
fluorouracil IV continuously on days 1-4. Group 2 (prior cisplatin with fluorouracil):
Patients receive cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Both
groups: Treatment repeats every 3 weeks for 2 courses. Patients who achieve partial or
complete response after completion of course 2 are taken off study. Patients with stable
disease or disease progression after completion of course 2 proceed to part II of the study.
Part II (courses 3-6): Patients are stratified by response to initial cisplatin-based
chemotherapy regimen (stable disease vs disease progression). Patients receive a test dose
of cetuximab IV over 10 minutes on day 1. Patients who do not experience grade 4
anaphylactic reaction receive a loading dose of cetuximab IV over 2 hours beginning 30
minutes after completion of test dose. Patients receive cisplatin IV over 1 hour beginning 1
hour after completion of cetuximab infusion on day 1. Patients receive maintenance cetuximab
IV over 1 hour on day 8. Maintenance cetuximab repeats weekly. Combination treatment repeats
every 3 weeks for a maximum of 4 courses. Patients with stable or responding disease after
completion of course 6 may continue to receive cetuximab alone in the absence of disease
progression and at the discretion of the protocol investigator and sponsor. Quality of life
is assessed before course 1, at the completion of courses 2, 4, and 6, and then at 4 weeks
after completion of study. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: Approximately 175 patients will be accrued for this study within 8
months.