Neoadjuvant Chemotherapy With Docetaxel, Cisplatin Followed by Maintenance Therapy With the EGFR Inhibitor Erlotinib (Tarceva) in Patients With Stage I, II and III Non-Small Cell Lung Cancer Following Definitive Surgical Resection
Erlotinib (Tarcevaâ, 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 (Taxotereâ) are commonly used
chemotherapy drugs. These drugs are designed to target and destroy cancer cells.
If you are found to be eligible, you will begin receiving chemotherapy with cisplatin and
docetaxel. Cisplatin and docetaxel will be given by vein once every 3 weeks. Both will be
given on the same day every 3 weeks. Docetaxel is given first over 1 hour. Cisplatin is
given second over 30 minutes to 1 hour. You will receive three 3-week cycles of
chemotherapy while on this study. Treatment with erlotinib will begin after you have had
surgery to remove the lung cancer. You will take erlotinib by mouth every day for the
remainder of your treatment on this study.
While taking chemotherapy, you will have blood tests every 3 weeks to look at your blood
counts. This is to ensure that your body has recovered from the chemotherapy enough to
continue treatment. About 2 teaspoons of blood will be needed for each test. These samples
will be used only for routine lab tests. You will be seen by a physician every 3 weeks. At
these visits, you will have a physical exam and a chest x-ray. You may have a neurological
exam if your doctor thinks it is necessary. This exam will look at whether you have any
numbness, test your hearing and vision, and will include other standard evaluations. Your
vital signs and weight will be monitored and you will be asked about certain side effects.
If necessary, depending on your side effects, you may need to have more frequent visits to
see your physician.
After 3 cycles of chemotherapy (9 weeks), you will have a CT scan of the chest and abdominal
area, and possibly a CT scan of the area where the disease may be coming back. These are
done to check the status of the disease.
Within 90 days after surgery, you will begin taking erlotinib. On Day 1 of erlotinib
treatment, you will have a physical exam, a performance status evaluation (questions about
your ability to perform everyday activities), a chest x-ray, and blood drawn (about 2
teaspoons) for routine tests. These tests will be repeated at Month 2, Month 3, then every 3
months after that.
On Day 1 of erlotinib treatment and every 3 months after that, you will also have a CT scan
of the chest and abdominal area, and possibly a CT scan of the area where the disease may be
You may receive treatment in the study for up to 1 year (3 cycles of cisplatin/docetaxel and
then daily erlotinib for up to 1 year) and will receive long-term follow-up (for 5 years
total) with your physician to monitor your condition and disease status. Your doctor may
decide to take you off this study if you experience significant side effects or your medical
condition worsens. Follow-up visits will include a chest x-ray and CT scan every 3 months
during Year 2 and then every 6 months until Year 5.
This is an investigational study. Erlotinib is approved by the FDA for treatment of
non-small cell lung cancer. Its use in this study is experimental. Docetaxel and cisplatin
are FDA approved and commercially available. A total of 50 patients will take part in this
study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Changes that occur in epidermal growth factor receptor (EGFR) and how these changes are reflected in different cells.
William N. William Jr., MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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