Reduced-intensity Therapy for Advanced Oropharyngeal Cancer in Non-smoking Human Papilloma Virus (HPV)-16 Positive Patients
The investigators have shown in past experience a high success in getting rid of
oropharyngeal cancer (tonsil or base of tongue cancer) using chemotherapy and radiation
therapy in patients who have not smoked, or only smoked a minimal amount of cigarettes or
equivalent. In these patients, the cancer is thought to be caused by a virus (Human
Papilloma Virus, or HPV). HPV is a virus that infects the epidermis (outermost layer of
skin) and mucous membranes of humans. In general, patients with HPV-related cancer such as
yours have a better prognosis compared with patients whose tumors are smoking-related.
Taking into account the good prognosis, it is possible that reducing the intensity of
therapy will not affect the high rate of tumor control, while reducing the side-effects of
therapy. In this study, the investigators plan to reduce the intensity of treatment by
replacing the currently used chemotherapy drugs with an FDA approved drug, cetuximab, which
is a monoclonal antibody to a growth factor which helps cancer cells grow. By opposing the
effect of the growth factor, cetuximab may help radiotherapy kill cancer cells without a lot
of effect on the normal tissue. It differs from chemotherapy in its more selective activity
against tumors compared to normal tissue Cetuximab has the chance to preserve the high rate
of success in killing the tumor but may reduce the side effects and complications of therapy
in comparison to chemotherapy drugs.
The investigators would also like to know if taking cetuximab has any effect on certain
cancer-related molecules in the cancer and the normal cells inside the cheek. They would
like to test this by taking a small biopsy of the tumor, as well as a swab of the inside of
the cheek, before and shortly after the start of therapy.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of Recurrence
To confirm that reducing treatment intensity in patients with HPV ¬related oropharyngeal cancer and < 10 pack-year smoking history by replacing concurrent chemotherapy with concurrent cetuximab, does not significantly increase the proportion of patients whose tumors recur, compared to our previous experience in similar patients receiving chemo-RT.
Timepoints throughout 3 years
Avraham Eisbruch, MD
University of Michigan Cancer Center
United States: Institutional Review Board
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