Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193284
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2005-09-12
Brief Title:
Chemotherapy Plus Gefitinib Followed by Chemotherapy Radiation Therapy and Gefitinib For Head and Neck Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase III Trial of Induction Chemotherapy Plus Gefitinib Iressa Followed by Concurrent Chemotherapy Radiation Therapy and Gefitinib Iressa For Patients With Locally Advanced Squamous Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2009-01
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:
Although gefitinib has been combined successfully with various chemotherapeutic regimens with minimal increase in overall toxicity experience with concurrent radiation therapy is limited In this trial we will evaluate the feasibility toxicity and effectiveness a novel combination of chemotherapy radiation therapy and gefitinib
Detailed Description:
Upon determination of eligibility patients will receive
Induction Therapy
Docetaxel
Carboplatin
5-FU
Gefitinib
Combined Modality Therapy
Cohort 1
Radiation therapy
Gefitinib
Cohort 2
Radiation therapy
Gefitinib
Docetaxel
Induction Therapy
Docetaxel
Carboplatin
5-FU
Gefitinib
Combined Modality Therapy
Cohort 1
Radiation therapy
Gefitinib
Cohort 2
Radiation therapy
Gefitinib
Docetaxel
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIT 15038 | None | None | None |
| IRUSIRES0047 | None | None | None |