Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096512
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2004-11-09
Brief Title:
S0420 Sorafenib in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of BAY 43-9006 NSC-724772 in Patients With Recurrent or Metastatic Head and Neck Cancer
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:
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth It may also stop the growth of tumor cells by stopping blood flow to the tumor This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cance
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response probability confirmed complete and partial responses in patients with metastatic head and neck cancer who are treated with BAY 43-9006
II To evaluate median progression-free survival and median overall survival III To evaluate the qualitative and quantitative toxicities of this regimen IV To investigate in a preliminary manner the effects of the agent on the Ras signal transduction pathway in tissue samples obtained prior to and after treatment
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 33-8 months
I To evaluate the response probability confirmed complete and partial responses in patients with metastatic head and neck cancer who are treated with BAY 43-9006
II To evaluate median progression-free survival and median overall survival III To evaluate the qualitative and quantitative toxicities of this regimen IV To investigate in a preliminary manner the effects of the agent on the Ras signal transduction pathway in tissue samples obtained prior to and after treatment
OUTLINE This is a multicenter study
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 33-8 months
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 |
|---|---|---|---|
| S0420 | None | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000393212 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |