Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT00509002
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2007-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Iressa Study in Patients With Salivary Gland Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2010-00744 | REGISTRY | NCI CTRP | View |