Phase II Study of C225 (Erbitux or Cetuximab) in Combination With Cisplatin and Definitive Radiation in Unresectable Stage IV Squamous Cell Carcinoma of the Head and Neck
- Determine 2-year progression-free survival in patients with unresectable locally
advanced or regional stage IV squamous cell or undifferentiated carcinoma of the head
and neck treated with cetuximab, cisplatin, and definitive radiotherapy.
- Determine response rate and overall survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Correlate epidermal growth factor receptor (EGFR) expression by immunohistochemistry,
EGFR phosphorylation, map kinase, Akt, signal transducer and activator of transcription
3 (STAT3), and other tissue and serum tests with toxicity of this regimen and outcomes
in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to tumor site
(hypopharynx vs. oropharynx vs. oral cavity vs. larynx), primary tumor stage (T1-3 vs. T4),
and nodal status (N0 vs. N1 vs. N2-3).
- Cetuximab therapy: Patients receive an initial loading dose of cetuximab IV over 2
hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29,
36, 43, 50, and 57.
- Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo
radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive
cisplatin IV over 1-2 hours on days 15, 36, and 57.
- Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients
continue to receive cetuximab IV over 1 hour once weekly for 6-12 months.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 10 years.
ACCRUAL: A total of 69 patients were accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2-year Progression-free Survival Rate
Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.
assessed every 3 months for 2 years
Corey J. Langer, MD
Fox Chase Cancer Center
United States: Federal Government