Conditions: Head and Neck Cancer Cancer of the Pharynx Cancer of the Larynx Nose Neoplasms Paranasal Sinus Neoplasms Cancer of the Oral Cavity
Keywords: Cancer of the Nasal Cavity
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 33
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Patients with stage IVA and IVB or high-risk stage III squamous cell carcinomas of the head and neck

Interventions: intervention 1: Cetuximab intervention 2: Hydroxyurea intervention 3: Fluorouracil intervention 4: radiotherapy
Intervention descriptions: intervention 1: 250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients intervention 2: 500 mg orally every 12 hours with the morning dose administered 2 hours before radiation intervention 3: continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours intervention 4: 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.

Protocol document: