Salivary Gland Cancer Clinical Trial
Official title:
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)
The goal of this clinical research study is to learn if ZD1839 (Iressa®, gefitinib can help to shrink or slow the growth of advanced, recurrent, or metastatic salivary gland cancer. The safety of this drug will also be studied.
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 growing.
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.
Anderson.
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