Phase I Study of High Dose Gefitinib (Iressa) for the Treatment of Carcinomatous Meningitis in Adult Patients With Non-Small Cell Lung Cancer and Known or Suspected EGFR Mutations
- The standard therapy for this type of cancer is to give chemotherapy directly into the
spinal fluid, usually by a spinal tap. Some chemotherapy may, in some cases, be
combined with radiation. This study looks at a different way of treating this type of
- This study is specifically for patients whose lung cancer has changes in a protein
called the epidermal growth factor receptor (EGFR). The study drug, gefitinib, was
developed to stop the signals from the EGFR that tell certain types of lung cancers
tumors to grow. By using higher doses than are normally used, we hope to increase the
amount of drug in the spinal fluid to attempt to kill the cancer cells around the
spinal cord and brain.
- Since we are looking for the highest dose of gefitinib that can be given safely, not
everyone who participates in this study will be receiving the same amount of drug.
- Patients will start taking gefitinib daily by mouth on Day 1 and will continue taking
this medication daily at home. On the first day the patient takes gefitinib and on Day
14 of each treatment cycle (1 cycle equals 28 days), the patient will undergo: Physical
examination by the study doctor and a detailed neurological exam by a neuro-oncologist;
sampling of cerebrospinal fluid (CSF) by lumbar puncture; review of current
medications; measurement of vital signs; check on the patients ability to perform daily
activities; blood work.
- If the patient is tolerating the study medication well, then the patient will receive a
lower dose for days 15-28 of the cycle.
- At the end of each cycle on Day 28, the patient will meet with the study doctor and
have the following: a physical examination; review of current medications; measurement
of vital signs, check on the patients ability to perform daily activities; blood tests;
MRI of the brain and spinal cord to assess tumor response; every two cycles a CT scan
of the chest and abdomen to assess the tumor response.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the safety of administering gefitinib in doses of 750mg to 1250mg in adult patients with carcinomatous meningitis from non-small cell lung cancer with known or suspected somatic EGFR mutations.
Bruce Johnson, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|