Phase II Study of ZD1839 (Iressa®), Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor in Patients With Advanced, Recurrent or Metastatic Salivary Gland Cancer (IRUSIRES0198)
Epidermal growth factor receptor (EGFR) may be involved in certain types of cancer,
including squamous cell carcinoma of the skin. When EGFR is stimulated, a series of
chemical reactions starts that results in a tumor being "told" to grow. ZD1839 (Iressa® or
Gefitinib) tries to stop these reactions by blocking EGFR. This may stop tumors from
Before you can start treatment on the study, you will have what are called "screening
tests". These tests will help the doctor decide if you are eligible to take part in the
study. You will have a physical exam, and a CT scan to check on the size and location of the
tumor. If the diagnosis has not yet been confirmed, a tumor sample (biopsy) may need to be
collected. During this biopsy, a tumor sample and a sample of normal skin will be taken with
a large needle. Women who are able to have children must have a negative blood or urine
If you are eligible to take part in this study, you will take gefitinib treatment by mouth
once a day, every day, at about the same time in the morning. It can be taken with or
without food. If you forget to take a dose, the last missed dose should be taken as soon as
you remember, as long as it is at least 12 hours before the next dose is due to be taken.
Every four weeks during treatment, you will have a physical exam and blood (around 3-4
teaspoons) will be collected for routine tests. If you have skin lesions, the lesions will
be measured and photographed for research purposes. You cannot be identified from the
pictures. 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 check-ups.
Every eight weeks during treatment, you will have imaging tests. The imaging tests include,
a chest x-ray and a CT scan or MRI 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 will continue to take gefitinib as long as the disease is responding to treatment. 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.
Sometimes, new information becomes available that may influence your decision to continue in
the study. The following new information is available:
Results from two large studies showed that there was no benefit from adding gefitinib to
chemotherapy with platinum and one other chemotherapy drug when given as the first treatment
for non-small cell lung cancer (NSCLC). Therefore, gefitinib is not approved for use in
combination with chemotherapy in the treatment of NSCLC.
This is an investigational study. The FDA has authorized gefitinib for use in cancer
research. Up to 80 patients will take part in this study. All will be enrolled at M. D.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate in Patients
Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal
George Blumenschein, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|