A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer
OSI-774 is a drug that helps to block the activity of an enzyme that is believed to play an
important role in cell growth. It is hoped that blocking these enzymes will slow tumor
growth. Both cisplatin and docetaxel are commonly used chemotherapy drugs. These drugs are
designed to target and destroy cancer cells.
Before the study, you will have a physical exam, blood tests (around 2 teaspoons), and an
electrocardiogram (ECG - a test that measures the electrical activity of the heart). You
will also have a chest x-ray and a CT scan. If the diagnosis has not yet been confirmed, a
biopsy of the tumor may need to be done. Women who are able to have children must have a
negative blood or urine pregnancy test.
During treatment, you will take OSI-774 by mouth once a day. Once every 3 weeks, you will
be given docetaxel and cisplatin. Docetaxel is given by a continuous infusion into a vein
over 1 hour. This will be followed by an infusion into a vein of cisplatin over 2 hours.
Treatment with docetaxel and cisplatin is given every 3 weeks for 18 weeks. You will
continue to take OSI-774 until your disease worsens, until side effects become too severe,
or until your doctor thinks it is no longer benefiting you.
If at any time during the study the disease becomes worse or you experience any intolerable
side effects, you will be taken off the study and your doctor will discuss other treatment
options with you.
During the study, you will have blood drawn (around 2 teaspoons) once a week. These samples
will be used for routine lab tests. Every 3 weeks, you will have a physical exam and your
vital signs and weight will be measured. You will also be asked about any side effects you
may be experiencing. If your doctor feels it is necessary, you may have more frequent
Every 6 weeks during treatment, you will have blood tests (around 2 teaspoons), and imaging
tests. The imaging tests include a chest x-ray and a CT scan of the head and neck area.
You may also have CT scans of other areas of the body. These tests are being done to check
on the status of the disease.
You may continue receiving OSI-774 for as long as your cancer responds to study treatment.
If you continue to receive OSI-774, every 3 months you will have a physical exam (including
measurement of vital signs), routine blood tests (about 2 teaspoons), a performance status
test (a test looking at the ability to perform everyday activities), a chest x-ray, and a CT
or MRI scan. Your doctor may decide to take you off this study if you experience
significant side effects or your medical condition worsens.
This is an investigational study. OSI-774 is approved by the FDA for treatment of NSCLC in
patients who have relapsed. Its use in this study is considered investigational.
Docetaxel and cisplatin are FDA approved and commercially available. There will be a total
of 50 patients taking part in this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer.
Every 6-8 weeks
Edward S. Kim, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|