A Phase I Study Of Bevacizumab (Recombinant Humanized Monoclonal Antibody To Vascular Endothelial Growth Factor) In Addition To Flourouracil And Hydroxyurea As Initial Chemotherapy With Concomitant Radiotherapy (B-FHX) For Poor Prognosis Head And Neck Cancer
I. Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when given
in combination with fluorouracil, hydroxyurea, and radiotherapy in patients with advanced
head and neck cancer.
II. Determine the time to progression, pattern of failure, local control, and distant
failure rate in patients treated with this regimen.
III. Determine the local toxic effects of this regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of bevacizumab.
Patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously
on days 1-5, and bevacizumab IV over 90 minutes on day 1. Patients also undergo radiotherapy
once daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12.
Treatment repeats every 2 weeks for up to 7 courses in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated
at the MTD.
PROJECTED ACCRUAL: A total of 27-39 patients will be accrued for this study within 5.4-19.5
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity assessed using NCI CTCAE version 3.0
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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