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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 use 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. Combining chemotherapy with monoclonal antibody therapy and radiation therapy may kill more tumor cells.
OBJECTIVES: I. Determine the response rate in patients with newly diagnosed or recurrent, advanced stage III or IV squamous cell carcinoma of the head and neck treated with 6 infusions of cetuximab at loading/maintenance doses in combination with 2 infusions of cisplatin concurrent with standard/delayed accelerated hyperfractionated radiotherapy followed by 4 weeks of single agent cetuximab. II. Assess the safety profile of this treatment regimen in this patient population. III. Evaluate time to disease progression and survival in these patients treated with this regimen. IV. Assess the impact of this treatment regimen on the quality of life of these patients.
OUTLINE: Patients receive a loading dose of cetuximab IV over 120 minutes on week 1 followed by 5 weekly maintenance doses over 60 minutes on weeks 2-6. Patients receive cisplatin IV over 30 minutes on weeks 1 and 4 beginning 1 hour after completion of cetuximab infusion. Radiotherapy is administered once daily during weeks 1-4 and twice daily during weeks 5 and 6. Following the initial 6 weeks of treatment, patients receive additional cetuximab IV over 30 minutes weekly on weeks 7-10. Quality of life is assessed at baseline, within 4 weeks after completion of all treatment, and at 3-4 months. Patients are followed at 4-6 weeks, 12-16 weeks, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Primary Purpose: Treatment
Head and Neck Cancer
cetuximab, cisplatin, radiation therapy
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:38-0400
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