A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
Erlotinib is designed to block the activity of a protein called epidermal growth factor
(EGFR). EGFR is 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 take erlotinib every
day for 7 weeks (except on the days you receive chemotherapy). The erlotinib tablets should
be taken at the same time each day, at least 1 hour before or 2 hours after a meal, with a
small glass (about 7 ounces) of water. If you are unable to swallow tablets, you may
dissolve the tablets in distilled water to drink.
You will receive radiation every day (Monday through Friday) for 7 weeks. You will also
receive chemotherapy through a needle in a vein once a week for 7 weeks. The chemotherapy
will include carboplatin and paclitaxel. Receiving chemotherapy will take about 6 hours
You will receive consolidation therapy on weeks 11-17.
Treatment on this study will last 17 weeks. Once a week during that time, you will have
blood (about 2 tablespoons) drawn for routine tests. You will also have a CT scan of the
chest within about 4 weeks from beginning the study, 2 months after finishing therapy, and
then every 6 months after that for 2 years. The CT scans are used to check the status of
You will be taken off study if the disease gets worse or intolerable side effects occur. In
this case, you would not receive erlotinib anymore but would continue standard chemotherapy
and radiation therapy.
You will be asked to come in to the clinic for follow-up visits to check on your recovery
from treatment. The follow-up visits will be at the end of all treatment, 1 month after
treatment, and then once a month for as long as your doctor feels it is necessary. Once
your side effects have become less severe, you will be asked to come in to the clinic for
follow-up visits every 3 months for 2 years, and then every 4 months for the following 2
years after that. You will have a physical exam, and your medical history will be recorded.
You will be asked about any side effects you may have. Blood (about 2 tablespoons) will be
drawn for routine tests. You will have a PET scan.
You have the right to leave the study at any time. If you choose to stop participating in
this study, you should contact the study chair and/or research nurse. Your doctor may decide
to take you off this study if your medical condition gets worse and/or you are unable to
comply with study requirements.
At the end of the study you will not be automatically notified of the research findings. If
you wish to learn about the results, however, you may request them from the study chair.
This is an investigational study. All three study drugs are commercially available.
Carboplatin, and paclitaxel are FDA approved for the treatment of NSCLC, but their use in
combination with erlotinib is not. Erlotinib is FDA approved for some uses, but it has not
been approved by the FDA to treat lung cancer patients like yourself who have not yet
undergone chemotherapy; however, the FDA has permitted its use in this research study.
Carboplatin and paclitaxel are considered standard of care treatment and you would probably
be treated with these drugs or similar drugs even if you decided not to be in the study.
Up to 48 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Disease Progression
Time measured in months from treatment to disease progression, follow up every 6 months.
Up to 4 years
Ritsuko R. Komaki, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|