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About
The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).
Full description
The Study Drugs:
Erlotinib hydrochloride 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.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take the study drug on Days 1-6 before receiving radiation therapy. You will take 1 pill each day at least 1 hour before or 2 hours after eating. You will take the study drug while you are receiving radiation therapy. You will continue to take the study drug daily after the radiation therapy is complete for as long as the study doctor thinks it is necessary.
You will record at what time each day you take the study drug on a calendar that the will be provided to you. You will bring this calendar with you to each of your study visits.
During the time you are taking the study drug, you must tell the research staff if you have any changes in the drugs that you are taking. If you feel you are having any problems from the study drug before starting radiation therapy, you must tell the study doctor right away.
Radiation Therapy:
After Day 6 of taking the study drug, you will begin radiation therapy. You will receive radiation therapy 1 time each day (Monday through Fridays only) for a total of 14 days.
Once a week during radiation therapy:
One month after Radiation therapy follow up:
Follow-up Visits (While on Tarceva):
If, at the end-of-study visit, the doctor decides that you will continue to take the study drug, you will have a follow-up visit with the research nurse 1 time each month. At these visits, the following tests and procedures will be performed:
(If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to mail study Tarceva medication.)
The following tests and procedures will be performed every 3 months:
Follow up visit (Discontinuation of Study Drug):
You will have a follow up visit with the research nurse 1 month after your last dose of the study drug, and the following will be performed:
(If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to have the study Tarceva medication and medication diary returned by mail.)
The following tests and procedures will be performed every 3 months (off Tarceva) for the first 2 years then every 6 months thereafter:
Duration of Study Treatment:
You will remain on study for as long as the study doctor thinks you are benefitting from the study drug. You will be taken off study treatment early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to continue to receive treatment on this study.
This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially available. It has not been FDA approved to treat NSCLC that has spread to the brain.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
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44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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