Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281840
Status:
COMPLETED
Last Update Posted:
2015-06-09
First Post:
2006-01-24
Brief Title:
Bevacizumab Docetaxel and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2015-05
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:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving bevacizumab together with docetaxel and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with docetaxel and radiation therapy works in treating patients with stage III or stage IV head and neck cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with docetaxel and radiation therapy works in treating patients with stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Determine the time to progression in patients with stage III or IV squamous cell carcinoma of the head and neck treated with bevacizumab in combination with docetaxel and radiotherapy
Secondary
Compare the objective response rate locoregional control rate duration of response patterns of failure and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients undergo radiotherapy once daily 5 days a week for 8 weeks and receive docetaxel IV over 1 hour once a week for 8 weeks Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year
Approximately 8-10 weeks after the completion of chemoradiotherapy patients may undergo neck dissection Bevacizumab which stops 8 weeks before surgery may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the time to progression in patients with stage III or IV squamous cell carcinoma of the head and neck treated with bevacizumab in combination with docetaxel and radiotherapy
Secondary
Compare the objective response rate locoregional control rate duration of response patterns of failure and overall survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients undergo radiotherapy once daily 5 days a week for 8 weeks and receive docetaxel IV over 1 hour once a week for 8 weeks Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year
Approximately 8-10 weeks after the completion of chemoradiotherapy patients may undergo neck dissection Bevacizumab which stops 8 weeks before surgery may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE6304 | OTHER | None | None |
| 03-05-50 | OTHER | University Hospitals IRB | httpsreporternihgovquickSearchP30CA043703 |