Phase II Trial of Induction Therapy With Cetuximab (C225) and Carboplatin/Paclitaxel Chemotherapy in Previously Untreated Patients With Advanced (Stage IV) Head & Neck Squamous Cell Carcinoma
- Determine the increase in clinical/radiographic complete response rate in patients with
previously untreated metastatic squamous cell carcinoma of the head and neck treated
with induction therapy comprising cetuximab, carboplatin, and paclitaxel.
- Determine the toxic effects of this regimen in these patients.
- Determine the pattern of tumor recurrence in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the duration of response, time to progression, and survival of patients
treated with this regimen.
- Correlate effects of this regimen with biomarkers of response and predictors of
long-term outcome in these patients.
OUTLINE: This is a nonrandomized, open-label study.
Patients receive induction therapy comprising cetuximab IV over 1-2 hours, paclitaxel IV
over 1 hour, and carboplatin IV over 1 hour on day 1. Treatment repeats weekly for up to 6
courses in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks
later, patients undergo radiotherapy or chemoradiotherapy. Patients with T0, 1, 2 disease
undergo radiotherapy 5 days a week for 6 weeks. Patients with T3, 4 disease or unresectable
nodal disease undergo radiotherapy 5 days a week for 6 weeks and receive concurrent
cisplatin IV over 1-2 hours on days 1 and 22. Some patients may undergo primary surgical
resection before or instead of radiotherapy or chemoradiotherapy.
Quality of life is assessed at baseline and at 6, 12, and 24 months after completion of
radiotherapy or surgery.
After study completion, patients are followed every 3 months for 2 years, every 4 months for
1 year, and every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Complete Response
Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.
Study period of 3 Years
Merrill S. Kies, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|