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Sponsors and Collaborators: |
M.D. Anderson Cancer Center AstraZeneca |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00509002 |
Primary Objective:
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.
Secondary Objectives:
Exploratory Objectives:
Condition | Intervention | Phase |
---|---|---|
Salivary Gland Cancer |
Drug: ZD1839 (Iressa) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 80 |
Study Start Date: | May 2004 |
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. 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. Gefitinib will be provided free of charge during the study. Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | George Blumenschein, MD | U.T.M.D. Anderson Cancer Center |
Study ID Numbers: | 2004-0089 |
Study First Received: | July 26, 2007 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00509002 |
Health Authority: | United States: Institutional Review Board |
Salivary Gland Cancer Iressa ZD1839 |
Mouth Diseases Oral cancer Head and Neck Neoplasms Stomatognathic Diseases Gefitinib |
Mouth Neoplasms Salivary Gland Diseases Recurrence Salivary Gland Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |