Head and Neck Cancer Clinical Trial
Official title:
A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells. Drugs used in
chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells
from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to
damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to
radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them
after surgery may kill any remaining tumor cells.
PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with
chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab
given together with chemoradiotherapy using docetaxel in treating patients with resected
stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and
neck.
OBJECTIVES:
Primary
- Compare disease-free survival of patients with resected stage III or IV squamous cell
carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in
combination with chemoradiotherapy comprising docetaxel vs cisplatin.
Secondary
- Compare the safety and efficacy of these regimens in these patients.
- Compare locoregional control and overall survival rates in patients treated with these
regimens.
- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT,
Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients
treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod
performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2 positive
nodes or extracapsular nodal extension]) and use of intensity-modulated radiotherapy (no vs
yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then
receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on
days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5
days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).
- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also
receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and
43 (weeks 2-7).
Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and
then annually thereafter.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within approximately 29 months.
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