Stage IV Squamous Cell Carcinoma of the Hypopharynx Clinical Trial
Official title:
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
This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works better in treating patients who have recurrent or metastatic head and neck cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may kill more tumor cells.
PRIMARY OBJECTIVES:
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, multicenter
study.
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 unacceptable
toxicity.
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
days 1-28.
Arm II: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on
days 1-28.
All subsequent courses: All patients receive bevacizumab as in arm II and oral erlotinib on
days 1-21.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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