Phase II Trial Using Erbitux+ Taxotere With Low Dose Fractionated Radiation for Recurrent Unresectable Locally Advanced Head and Neck Carcinoma
The investigator's approach is based on the following reasons:
- Low dose hyper-radiation sensitivity response will be significantly enhanced in
Taxotere- induced G2/M cell cycle arrest.
- LDFRT will render enhanced bax activation mediated mode of cell death.
- Erbitux will arrest the cells in G1/G0 phase leading to p21-mediated mode of cell
- The toxicity profile is expected to be minimal.
Based on the above mentioned reasons, we propose this novel schema of treatment in recurrent
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate of Participants
The primary objective is to show improvement of the overall response rate from the current standard of 40% with chemotherapy alone, to 70% with the addition of LDFRT, in patients with recurrent unresectable head and neck squamous cell carcinoma.
Matthew C Abramowitz, MD
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|