A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded
prognosis. Improvements in outcome have been achieved via the combination of chemotherapy
and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although
recent data suggest a benefit from induction therapy as well. Nonetheless, despite high
remission rates, most of these patients will suffer local-regional and/or distant recurrence
from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus
concurrent) via the addition of a double biologic therapy. Specifically, the combination of
bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
Pramila Rani Anne, MD
Thomas Jefferson University
United States: Food and Drug Administration
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|