NCT00462735

Fluorouracil, Hydroxyurea, Cetuximab and Twice-daily Intensity Radiation Therapy for Advanced Head and Neck Cancer

Phase II Study of Concomitant Fluorouracil, Hydroxyurea, Cetuximab and Hyperfractionated Intensity Modulated Radiation Therapy for Locally Advanced Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Johnny Kao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer
• Cancer of the Pharynx
• Cancer of the Larynx
• Nose Neoplasms
• Paranasal Sinus Neoplasms
• Cancer of the Oral Cavity

Interventions

Type	Name	Description
DRUG	Cetuximab	250 mg/m2 on Day 1 after the first dose of radiation was administered to all patients
DRUG	Hydroxyurea	500 mg orally every 12 hours with the morning dose administered 2 hours before radiation
DRUG	Fluorouracil	continuous-infusion 5-FU at a dose of 600 mg/m2 daily for 120 hours
PROCEDURE	radiotherapy	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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2007-04-19
• Last updated: 2018-03-13
• Results posted: 2018-03-13

Locations

1 site across 1 country: United States