Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390325
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2006-10-18
Brief Title:
Sorafenib Tosylate in Treating Patients With Metastatic Locally Advanced or Recurrent Medullary Thyroid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Sorafenib BAY 43-9006 in Patients With Metastatic Medullary Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-01
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:
This phase II trial studies how well sorafenib tosylate works in treating patients with medullary thyroid cancer that has spread to other parts of the body metastatic spread to the tissue surrounding the thyroid locally advanced or has returned after a period of improvement recurrent Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To assess objective response rate of sorafenib tosylate sorafenib BAY 43-9006 in metastatic medullary thyroid carcinoma in setting of inherited tumor syndromes such as multiple endocrine neoplasia MEN 2A MEN 2B or familial medullary thyroid carcinoma FMTC
II To assess objective response rate of sorafenib BAY 43-9006 in sporadic metastatic medullary thyroid carcinoma
SECONDARY OBJECTIVES
I To assess toxicity of sorafenib BAY 43-9006 in patients with metastatic medullary thyroid carcinoma
II Measure serum tumor markers calcitonin and carcinoembryonic antigen CEA pre- during and post-treatment to correlate with disease response
III Correlate nuclear medicine functional imaging fludeoxyglucose F 18 F-18 fluorodeoxyglucose positron emission tomography PET scan data obtained at pre- during and post-treatment with tumor response
IV Correlate dynamic contrast-enhanced magnetic resonance imaging DCE-MRI data obtained at pre- during and post-treatment with changes in tumor permeability and vascularity with tumor response
V Perform pharmacogenomic studies on procured peripheral blood mononuclear cells PBMCs if clinical responses are observed
VI To correlate between the degree of retrovirus-associated sequence Ras-mitogen-activated protein kinase MAPK signaling inhibition and vascular endothelial growth factor VEGF expression in the tumor and clinical response
VII To correlate between the presence and type of ret proto-oncogene RET gene defects in tumor and clinical response
OUTLINE
Patients receive sorafenib tosylate orally PO twice daily BID in the absence of disease progression or unacceptable toxicity
I To assess objective response rate of sorafenib tosylate sorafenib BAY 43-9006 in metastatic medullary thyroid carcinoma in setting of inherited tumor syndromes such as multiple endocrine neoplasia MEN 2A MEN 2B or familial medullary thyroid carcinoma FMTC
II To assess objective response rate of sorafenib BAY 43-9006 in sporadic metastatic medullary thyroid carcinoma
SECONDARY OBJECTIVES
I To assess toxicity of sorafenib BAY 43-9006 in patients with metastatic medullary thyroid carcinoma
II Measure serum tumor markers calcitonin and carcinoembryonic antigen CEA pre- during and post-treatment to correlate with disease response
III Correlate nuclear medicine functional imaging fludeoxyglucose F 18 F-18 fluorodeoxyglucose positron emission tomography PET scan data obtained at pre- during and post-treatment with tumor response
IV Correlate dynamic contrast-enhanced magnetic resonance imaging DCE-MRI data obtained at pre- during and post-treatment with changes in tumor permeability and vascularity with tumor response
V Perform pharmacogenomic studies on procured peripheral blood mononuclear cells PBMCs if clinical responses are observed
VI To correlate between the degree of retrovirus-associated sequence Ras-mitogen-activated protein kinase MAPK signaling inhibition and vascular endothelial growth factor VEGF expression in the tumor and clinical response
VII To correlate between the presence and type of ret proto-oncogene RET gene defects in tumor and clinical response
OUTLINE
Patients receive sorafenib tosylate orally PO twice daily BID in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| P30CA016058 | NIH | CTEP | httpsreporternihgovquickSearchP30CA016058 |
| NCI-2009-00196 | REGISTRY | None | None |
| 2006C0050 | None | None | None |
| NCI-7609 | None | None | None |
| CDR0000507441 | None | None | None |
| OSU 06054 IRB 2006C0050 | None | None | None |
| 7609 | OTHER | None | None |
| 7609 | OTHER | None | None |
| N01CM00070 | NIH | None | None |
| N01CM62207 | NIH | None | None |