Head and Neck Cancer Clinical Trial
Official title:
A Phase II Multi-Center Study of Concomitant Cetuximab and Cisplatin With Re-Irradiation Using Intensity-Modulated Radiotherapy in Patients With Recurrent Squamous Cell Carcinoma of the Head-and-Neck
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
cisplatin, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill
tumor cells. Giving cetuximab and cisplatin together with radiation therapy may kill more
tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab and cisplatin together
with radiation therapy works in treating patients with recurrent head and neck cancer.
OBJECTIVES:
Primary
- To evaluate whether treatment with cetuximab, cisplatin, and intensity-modulated
radiotherapy improves the overall survival of patients with recurrent squamous cell
carcinoma of the head and neck.
Secondary
- To determine the progression-free survival and local-regional progression in these
patients.
- To identify and estimate the incidence rate of acute and late toxicities associated with
this treatment regimen.
- To determine the pattern of disease progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive cetuximab IV over 60-120 minutes once weekly in weeks 1-7. Patients also
receive cisplatin IV over 60 minutes once weekly and undergo intensity-modulated radiotherapy
once daily 5 days a week in weeks 2-7.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 4 years.
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