Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330421
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2006-05-25
Brief Title:
Sorafenib in Treating Patients With Soft Tissue Sarcomas Extremity Sarcoma Closed to Entry as of 53007
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Clinical and Correlative Study of BAY 43-9006 Sorafenib IND 69896 in Sarcoma
Status:
COMPLETED
Status Verified Date:
2013-11
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 soft tissue sarcoma Sorafenib may stop the growth of soft tissue sarcoma by blocking blood flow to the tumor and blocking some of the enzymes needed for tumor cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine if the combined vascular endothelial growth factor receptor 2 VEGF-R2platelet-derived growth factor receptor PDGFR-beta inhibitor BAY 43-9006 sorafenib can decrease interstitial fluid pressure IFP in soft tissue sarcomas
II To investigate the effects of BAY 43-9006sorafenib on tumor blood flow circulating endothelial cells vascular density and pericyte coverage
III To characterize the pharmacokinetics of BAY 43-9006sorafenib in sarcoma patients
SECONDARY OBJECTIVES
I To describe any preliminary evidence of anti-tumor activity II Assess whether there are any significant relationships between systemic drug exposure and drug-related toxicity or biological effect
OUTLINE This is a multicenter study Patients are assigned to one of two groups group 1 closed to accrual as of 53007
GROUP I SARCOMAS OF THE EXTREMITY CLOSED TO ACCRUAL AS OF 53007 Patients receive oral sorafenib twice daily on days 1-14 Patients undergo surgical resection of the tumor on approximately day 15 Once patients recover from surgery and radiotherapy if indicated patients who demonstrate a clinically and pathologically significant response 25 reduction in tumor size or 25 necrosis in the surgical specimen may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure IFP is measured at baseline and immediately before surgery
GROUP II METASTATIC OR INOPERABLE SARCOMAS Patients receive oral sorafenib twice daily on days 1-28 Treatment repeats every 28 days for 2 courses Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56
In both groups blood samples are drawn periodically for pharmacological studies
After completion of study therapy patients are followed monthly until all study-related toxicities are resolved and then at the discretion of the investigator
I To determine if the combined vascular endothelial growth factor receptor 2 VEGF-R2platelet-derived growth factor receptor PDGFR-beta inhibitor BAY 43-9006 sorafenib can decrease interstitial fluid pressure IFP in soft tissue sarcomas
II To investigate the effects of BAY 43-9006sorafenib on tumor blood flow circulating endothelial cells vascular density and pericyte coverage
III To characterize the pharmacokinetics of BAY 43-9006sorafenib in sarcoma patients
SECONDARY OBJECTIVES
I To describe any preliminary evidence of anti-tumor activity II Assess whether there are any significant relationships between systemic drug exposure and drug-related toxicity or biological effect
OUTLINE This is a multicenter study Patients are assigned to one of two groups group 1 closed to accrual as of 53007
GROUP I SARCOMAS OF THE EXTREMITY CLOSED TO ACCRUAL AS OF 53007 Patients receive oral sorafenib twice daily on days 1-14 Patients undergo surgical resection of the tumor on approximately day 15 Once patients recover from surgery and radiotherapy if indicated patients who demonstrate a clinically and pathologically significant response 25 reduction in tumor size or 25 necrosis in the surgical specimen may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure IFP is measured at baseline and immediately before surgery
GROUP II METASTATIC OR INOPERABLE SARCOMAS Patients receive oral sorafenib twice daily on days 1-28 Treatment repeats every 28 days for 2 courses Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56
In both groups blood samples are drawn periodically for pharmacological studies
After completion of study therapy patients are followed monthly until all study-related toxicities are resolved and then at the discretion of the investigator
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 |
|---|---|---|---|
| 05-033 | None | None | None |
| U01CA062490 | NIH | None | httpsreporternihgovquickSearchU01CA062490 |