At a glance
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Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer
In Brief
A Phase 2 clinical trial evaluating Cetuximab, Hydroxyurea, and 2 other interventions for Head and Neck Cancer and 5 related conditions. Completed, enrolled 33 participants across 1 site.
Detailed Summary
For advanced head and neck cancer, combined radiation and chemotherapy prevents recurrences and for many patients, improves survival. While combined cisplatin and radiation or cetuximab and radiation is more effective than radiation alone, approximately 50% of these patients will still recur. A more aggressive approach may be needed for these patients to prevent recurrence and death. The strategy of using multiple chemotherapy drugs with radiation given twice a day has been tested at Mount Sinai and University of Chicago. Approximately 80% of patients are cured with this strategy. While cure rates are higher than standard chemotherapy and radiation and the treatment is tolerable, side effects during treatment are common. We propose replacing a chemotherapy drug with a less toxic, targeted therapy called cetuximab. Our goal is to reduce toxicity while maintaining or improving cure rates for these patients.
Study Details
Timeline
Interventions
250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
Radiotherapy was administered at 1.5 Gy per fraction twice daily with treatments separated by at least 6 hours on Days 1 through 5 on an alternating week schedule. Radiation was delivered with intensity-modulated radiation therapy (IMRT) planning for all patients.