Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405405
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2006-11-29
Brief Title:
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2016-10
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:
To determine a safe and effective doses of two biologic drugs erlotinib and bevacizumab when used with chemotherapy and radiation therapy in advanced head and neck cancer
Detailed Description:
Locally advanced non-operative Stage IV head and neck cancer has at best a guarded prognosis Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy Concurrent chemoradiotherapy is needed to optimize results although recent data suggest a benefit from induction therapy as well Nonetheless despite high remission rates most of these patients will suffer local-regional andor distant recurrence from their disease
The proposed study will build upon the framework of chemoradiotherapy induction plus concurrent via the addition of a double biologic therapy Specifically the combination of bevacizumab and erlotinib will be used as has been studied in other types of cancer
The proposed study will build upon the framework of chemoradiotherapy induction plus concurrent via the addition of a double biologic therapy Specifically the combination of bevacizumab and erlotinib will be used as has been studied in other types of cancer
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 |
|---|---|---|---|
| 2005-58 | OTHER | CCRRC | None |