Head and Neck Cancer Clinical Trial
Official title:
A Phase II Trial of Neoadjuvant Chemotherapy Plus Bevacizumab Followed By Concurrent Chemotherapy/Bevacizumab/Erlotinib/Radiation Therapy in the Treatment of Locally Advanced Squamous Carcinoma of the Head and Neck
Two new cancer treatment drugs called targeted therapies will be added to standard treatment for head and neck cancer to see if an improvement can be made in the effectiveness of treatment for this type of cancer. Treatment will include chemotherapy, radiation therapy and targeted therapy taken over a period of 4 months.
In this trial, patients will receive induction treatment with combination
chemotherapy(paclitaxel/carboplatin/infusional 5FU) plus bevacizumab. After 6 weeks of
treatment, patients will be reevaluated and will then receive concurrent radiation therapy,
chemotherapy (weekly paclitaxel),bevacizumab, and erlotinib.
Induction Treatment:
Paclitaxel 200mg/m2 by vein over 1-3 hours on Day 1 & Day 22 Carboplatin AUC 6.0 by vein
over 1 hour on Days 1 and 22 Bevacizumab 15mg/kg by vein over 60-90 minutes on Days 1 and 22
5-FU 200mg/m2 as a 24 hour continuous infusion via pump on Days 1 through 43.
Combined Modality Treatment:
Radiation therapy is given daily, Monday through Friday for approximately 7 weeks. Erlotinib
150mg by mouth daily during the entire course of radiation (approximately 7 weeks)
Paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation
therapy Bevacizumab 15mg/kg by vein over 30-90 minutes on Days 50 and 71 at the same time of
radiation therapy
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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