Iressa Study in Patients With Salivary Gland Cancer
1. To determine the response rate of in patients with advanced, recurrent, or metastatic salivary gland cancer who are not candidate for curative surgery or radiotherapy.
- To determine progression-free survival and overall survival.
- To determine disease control rate and duration.
- To determine time to disease progression.
- To further characterize the safety profile of 250 mg daily dose of ZD1839.
- To demonstrate the effectiveness of ZD1839 as an inhibitor of epithelial growth factor (EGFR) phosphorylation, MAP kinase activation, and vascular endothelial growth factor (VEGF) secretion in salivary gland cancer.
- To estimate the correlation of HER2/neu expression and the probability of tumor response.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Response Rate in Patients [ Time Frame: Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: ZD1839 (Iressa)
250 mg daily
Drug: ZD1839 (Iressa)
250 mg by mouth once a day, every day, at about same time in morning.
Other Name: gefitinib
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.
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 pregnancy test.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00509002
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||George Blumenschein, MD||M.D. Anderson Cancer Center|