Phase Ib Study of Erlotinib Prior to Surgery in Patients With Head and Neck Cancer
The Study Drug:
Erlotinib is designed to block the activity of a protein found on the surface of many tumor
cells that may control tumor growth and survival. This may stop tumors from growing.
If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the toss of a coin) to receive erlotinib at either the standard dose or the high
dose. There is an equal chance of being assigned to either group. If you are assigned to
the high dose group and you are a current smoker, you will receive an even higher daily dose
of erlotinib. Both you and your study doctor will know which group you are in.
Study Drug Administration:
Group 1 will take 1 tablet of erlotinib once a day, every day leading up to surgery.
Group 2 will take 2 tablets once a day, every day leading up to surgery. Depending on your
assigned dose level, the 2 tablets may contain the same drug amount or 2 different drug
Erlotinib should be taken at the same time of day, 1 hour before or 2 hours after a meal.
Each dose should be taken with 8 ounces of water. You should not consume grapefruit or
grapefruit juice while on this study.
If you vomit after taking the medication, you can take another dose again, but only if the
vomited tablet(s) can be seen and counted (in other words, they have not been digested yet).
Every 2 weeks, you will have a study visit. The following tests and procedures will be
- Your medical history will be recorded.
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be experiencing.
- You will have a CT scan or MRI to check the status of the disease within 1 week before
Within one week before your surgery, you will also have blood (about 2-3 teaspoons) drawn to
check your blood clotting function.
Length of Study:
You will be on study for at least 2-3 weeks up to the day before surgery. You may be on
study for up to 8 weeks if there is a delay in surgery.
After you have completed the study, you will have surgery to remove your tumor. During your
surgery, a sample of your tumor tissue that is already being removed will be collected to
check for biomarkers.
Within 30 days after your surgery, you will be contacted by phone to be asked you about any
side effects you have experienced. The phone call will last about 10 minutes.
This is an investigational study. Erlotinib is FDA approved and commercially available for
the treatment of non-small cell lung cancer and pancreatic cancer (first-line therapy in
combination with gemcitabine). Its use in this study is investigational.
Up to 55 patients will be enrolled in this study. All will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Effects of erlotinib 150 mg/day (standard dose) + 200 mg/day or 300 mg/day (high-dose) on phosphorylation of AKT protein downstream from EGFR
Treatment: 2-3 week period leading up to surgery; Disease reassessment (Imaging studies): 1 week before surgery.
William N. William Jr., MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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