Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392704
Status:
COMPLETED
Last Update Posted:
2013-02-22
First Post:
2006-10-25
Brief Title:
Treatment of Head Neck Cancer With Chemotherapy and Radiation
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase II Trial of Neoadjuvant Chemotherapy Plus Bevacizumab Followed By Concurrent ChemotherapyBevacizumabErlotinibRadiation Therapy in the Treatment of Locally Advanced Squamous Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-02
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:
Two new cancer treatment drugs called targeted therapies will be added to standard treatment for head and neck cancer to see if an improvement can be made in the effectiveness of treatment for this type of cancer Treatment will include chemotherapy radiation therapy and targeted therapy taken over a period of 4 months
Detailed Description:
In this trial patients will receive induction treatment with combination chemotherapypaclitaxelcarboplatininfusional 5FU plus bevacizumab After 6 weeks of treatment patients will be reevaluated and will then receive concurrent radiation therapy chemotherapy weekly paclitaxelbevacizumab and erlotinib
Induction Treatment
Paclitaxel 200mgm2 by vein over 1-3 hours on Day 1 Day 22 Carboplatin AUC 60 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mgkg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mgm2 as a 24 hour continuous infusion via pump on Days 1 through 43
Combined Modality Treatment
Radiation therapy is given daily Monday through Friday for approximately 7 weeks Erlotinib 150mg by mouth daily during the entire course of radiation approximately 7 weeks Paclitaxel 50mgm2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mgkg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy
Induction Treatment
Paclitaxel 200mgm2 by vein over 1-3 hours on Day 1 Day 22 Carboplatin AUC 60 by vein over 1 hour on Days 1 and 22 Bevacizumab 15mgkg by vein over 60-90 minutes on Days 1 and 22 5-FU 200mgm2 as a 24 hour continuous infusion via pump on Days 1 through 43
Combined Modality Treatment
Radiation therapy is given daily Monday through Friday for approximately 7 weeks Erlotinib 150mg by mouth daily during the entire course of radiation approximately 7 weeks Paclitaxel 50mgm2 by vein over 1-hour weekly for 6 weeks beginning Day 1 of radiation therapy Bevacizumab 15mgkg by vein over 30-90 minutes on Days 50 and 71 at the same time of radiation therapy
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