Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054691
Status:
COMPLETED
Last Update Posted:
2015-03-13
First Post:
2003-02-06
Brief Title:
ZD1839 Iressa for Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of ZD1839 Iressa Epidermal Growth Factor Receptor EGFR Tyrosine Kinase Inhibitor in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Skin
Status:
COMPLETED
Status Verified Date:
2015-02
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 the drug ZD1839 Iressa can shrink or slow the growth of cancer in participants with recurrent andor metastatic squamous cell cancer SCC of the skin The safety of this drug will also be studied
Detailed Description:
ZD1839 is a new drug that may slow or stop cell growth in humans
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 tries to stop these reactions by blocking EGFR This may stop tumors from growing
In this study participants will take ZD1839 by mouth daily Once the treatment has started participants will return to the clinic before every treatment cycle every 4 weeks for the first 4 months then every 8 weeks thereafter At these visits participants will have a physical exam and blood tests will be performed About 2-4 teaspoons of blood will be drawn at each visit The doctor will also check on how participants are tolerating ZD1839 side effects Every 8 weeks participants will have their tumor evaluated by radiographic scans This may include either a CT or MRI and a chest X-ray
During treatment participants should not take any other medication including non-prescription drugs such as aspirin or herbal products without the approval of their doctor
Participants will continue taking the trial drug until the tumor grows a severe side effect occurs they withdraw consent or the study is closed The study will be closed 12 months after the last participant is enrolled
This is an investigational study The FDA has approved ZD1839 for the treatment of advanced lung cancer but the FDA has authorized ZD1839 for research only in the treatment of skin cancer About 40 participants will take part in this study All will be enrolled at MD Anderson
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 tries to stop these reactions by blocking EGFR This may stop tumors from growing
In this study participants will take ZD1839 by mouth daily Once the treatment has started participants will return to the clinic before every treatment cycle every 4 weeks for the first 4 months then every 8 weeks thereafter At these visits participants will have a physical exam and blood tests will be performed About 2-4 teaspoons of blood will be drawn at each visit The doctor will also check on how participants are tolerating ZD1839 side effects Every 8 weeks participants will have their tumor evaluated by radiographic scans This may include either a CT or MRI and a chest X-ray
During treatment participants should not take any other medication including non-prescription drugs such as aspirin or herbal products without the approval of their doctor
Participants will continue taking the trial drug until the tumor grows a severe side effect occurs they withdraw consent or the study is closed The study will be closed 12 months after the last participant is enrolled
This is an investigational study The FDA has approved ZD1839 for the treatment of advanced lung cancer but the FDA has authorized ZD1839 for research only in the treatment of skin cancer About 40 participants will take part in this study All will be enrolled at MD Anderson
Study Oversight
Has Oversight DMC:
None
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?:
None