Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245102
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2005-10-25
Brief Title:
Sorafenib in Treating Patients With Metastatic Locally Advanced or Recurrent Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase II Study of Sorafenib BAY43-9006 in Non-GIST Sarcomas
Status:
COMPLETED
Status Verified Date:
2012-12
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 is studying how well sorafenib works in treating patients with metastatic locally advanced or recurrent sarcoma Sorafenib 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 The primary endpoint is the response rate CRPR for each stratum of sarcoma patients treated with sorafenib as defined by RECIST
SECONDARY OBJECTIVES
I Progression-free survival defined as CR PR SD assessed at 3 months or 6 months
II Overall survival III Pharmacokinetics of sorafenib in this patient population all sites will participate
IV Frequency of B-raf mutations in the patients sarcomas treated as part of this study and correlation with response or resistance to sorafenib all sites will participate
V Ras-raf kinase pathway activation in pre-treatment existing tumor specimens paraffin section immunohistochemistry all sites will participate
VI At MSKCC only Pre and post treatment specimen changes in downstream events of ras signaling specifically inhibition of ERK phosphorylation Only patients with angiosarcoma and MPNST will undergo biopsy up to 10 patients
VII At MSKCC only Circulating Endothelial Cells CECs VE-cadherin levels and soluble protein levels VEGF bFGF endostatin as a measures of angiogenesis before and after starting sorafenib therapy
OUTLINE This is an open-label non-randomized multicenter study Patients are stratified according to sarcoma histology angiosarcoma vs malignant peripheral nerve sheath tumor vs leiomyosarcoma closed to accrual as of 112906 vs high-grade undifferentiated pleomorphic sarcoma ie malignant fibrous histiocytoma including myxofibrosarcomaclosed to accrual as of 112906 vs synovial sarcoma closed to accrual as of 112906 vs all other types of sarcoma
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study patients are followed at 4 weeks
I The primary endpoint is the response rate CRPR for each stratum of sarcoma patients treated with sorafenib as defined by RECIST
SECONDARY OBJECTIVES
I Progression-free survival defined as CR PR SD assessed at 3 months or 6 months
II Overall survival III Pharmacokinetics of sorafenib in this patient population all sites will participate
IV Frequency of B-raf mutations in the patients sarcomas treated as part of this study and correlation with response or resistance to sorafenib all sites will participate
V Ras-raf kinase pathway activation in pre-treatment existing tumor specimens paraffin section immunohistochemistry all sites will participate
VI At MSKCC only Pre and post treatment specimen changes in downstream events of ras signaling specifically inhibition of ERK phosphorylation Only patients with angiosarcoma and MPNST will undergo biopsy up to 10 patients
VII At MSKCC only Circulating Endothelial Cells CECs VE-cadherin levels and soluble protein levels VEGF bFGF endostatin as a measures of angiogenesis before and after starting sorafenib therapy
OUTLINE This is an open-label non-randomized multicenter study Patients are stratified according to sarcoma histology angiosarcoma vs malignant peripheral nerve sheath tumor vs leiomyosarcoma closed to accrual as of 112906 vs high-grade undifferentiated pleomorphic sarcoma ie malignant fibrous histiocytoma including myxofibrosarcomaclosed to accrual as of 112906 vs synovial sarcoma closed to accrual as of 112906 vs all other types of sarcoma
Patients receive oral sorafenib twice daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study patients are followed at 4 weeks
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 |
|---|---|---|---|
| NCI-2012-01469 | REGISTRY | None | None |
| NCI-7060 | None | None | None |
| CDR0000449962 | None | None | None |
| MSKCC-05081 | None | None | None |
| 05-081 | OTHER | None | None |
| 7060 | OTHER | None | None |
| N01CM62206 | NIH | None | None |
| P30CA008748 | NIH | None | None |
| N01CM62201 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62201 |