To determine a safe and effective doses of two biologic drugs, erlotinib and bevacizumab when used with chemotherapy and radiation therapy in 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
* Two cycles during neoadjuvant therapy * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
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.
Time frame: Day 36
Determination of Dose Limiting Toxicity (DTL)
To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
Time frame: 30 days
Complete Remission Rate
To obtain preliminary data on the complete remission rate for this treatment combination.
Time frame: 6 months
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* Two cycles during neoadjuvant therapy (dose escalation) * Response assessment at approximately day 36 * Concurrent biochemoradiotherapy
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks