Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
Phase II Trial Evaluating Axitinib (AG-013736) In Patients With Unresectable, Recurrent Or Metastatic Head And Neck Cancer
The purpose of this study is to investigate a new agent Axitinib in the treatment of head
and neck cancer.
This is a new drug that is given as a pill twice a day to treat cancer. This is one of the
new, "smart" drugs. It binds to a protein on the surface of the cancer cell called VEGFR,
and this way it slows down the growth of cancer cells and kills them. Head and neck cancer
cells are known to carry this protein on their surface. Research in animals and in patients
with other kinds of cancer showed that Axitinib can be effective at killing cancer cells, or
stopping their growth, by this mechanism. It is generally a safe drug that is given by
mouth. The investigators do not know, however, whether Axitinib is effective in head and
neck cancer. This research study is being conducted to learn if Axitinib works in head and
neck cancer, and also to learn to predict who would benefit from it. Four blood draws will
be done to check special blood tests while the subjects are treated with Axitinib. These
will be drawn at the same time as your routine labs, and there will not be additional sticks
needed. A biopsy of the tumor before and after 1 month of treatment may be obtained to test
how the cancer cells are responding to treatment. By testing these blood and tissue samples,
the researchers will look at special tests (protein molecules) to try to determine what kind
of head and neck patients would best respond to this drug. This is an open-label study,
meaning that all subjects are on the active drug and there is no placebo (sugar pill).
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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