A Phase I/II Study Of Bevacizumab (rhuMAb VEGF) In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck
I. Determine the maximum tolerated dose and dose-limiting toxicity of bevacizumab when
administered with erlotinib in patients with recurrent or metastatic head and neck cancer.
II. Determine the objective response rate and stable disease/absence of early progression in
patients treated with this regimen.
OUTLINE: This is a dose-escalation study of bevacizumab followed by a randomized,
Phase I: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on
days 1-21. Courses repeat every 21 days 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 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.
Phase II: Course 1 is 28 days in length. All subsequent courses are 21 days.
Course 1: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on
Arm II: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on
All subsequent courses: All patients receive bevacizumab as in arm II and oral erlotinib on
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of bevacizumab when used in combination with erlotinib hydrochloride determined by dose-limiting toxicities (Phase I)
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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