Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228488
Status:
COMPLETED
Last Update Posted:
2007-12-19
First Post:
2005-09-27
Brief Title:
Effect of Iressa WithWithout Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Phase II Study of Iressa WithWithout Concurrent Chemoradiotherapy in Patients With Advanced Non-Nasopharyngeal Head and Neck Carcinoma and to Study the Effect of Iressa ZD1839 on Tumour Gene Expression Profiles
Status:
COMPLETED
Status Verified Date:
2007-12
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:
Two different patient populations will be targeted for this study The first population SP1 will include patients with recurrentmetastatic head and neck cancers excluding salivary gland carcinomas The second population SP2 will include treatment-naïve patients with locally advanced squamous cell head and neck cancer SCHNC
SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy Study treatment will consist of Iressa gefitinib alone
SP2 will be treated with radical intent The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation
SP1 will be treated with palliative intent and the patients can be treatment-naïve or have received prior chemotherapy Study treatment will consist of Iressa gefitinib alone
SP2 will be treated with radical intent The patients must be treatment-naïve and study treatment will consist of induction Iressa for 3 weeks followed by a combination of Iressa plus cisplatin and concurrent irradiation
Detailed Description:
None
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