Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450879
Status:
TERMINATED
Last Update Posted:
2015-03-25
First Post:
2007-03-20
Brief Title:
Pazopanib in Treating Patients With Newly Diagnosed or Locally andor Regionally Recurrent Breast Cancer That Can Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pilot Study of GW786034 Pazopanib a Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor in Patients With Operable Breast Cancer
Status:
TERMINATED
Status Verified Date:
2013-06
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 pilot clinical trial studies how well pazopanib hydrochloride works in treating patients with breast cancer that is newly diagnosed or has come back at or near the same place as the original tumor and can be removed by surgery Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by preventing the growth of new blood vessels necessary for tumor growth Giving pazopanib hydrochloride before surgery may make the tumor smaller and reduce the amount of tissue that needs to be removed
Detailed Description:
PRIMARY OBJECTIVES
I To determine the biologic effect measured by a decrease in phosphorylation of vascular endothelial growth factor receptor 2 VEGFR-2 andor decrease in microvessel density in breast tumor biopsies after treatment with daily oral GW786034 pazopanib hydrochloride for at least 12 consecutive days in early stage operable breast cancer or local andor regional recurrence that is amenable to surgery
II To determine the mechanism of antitumor effect measured by a reduction in tumor cell proliferation Ki67 or an increase in apoptosis in breast tumor biopsies after treatment with GW786034
SECONDARY OBJECTIVES
I To determine the change in levels of tissue vascular endothelial growth factor VEGF in breast tumor biopsies after treatment with GW786034
II To evaluate the change in phosphorylation of epidermal growth factor receptor EGFR mitogen-activated protein kinase MAPK and protein kinase B AKT in breast tumor biopsies after treatment with GW786034
III To identify gene expression patterns in breast tumor biopsies before and after treatment with GW786034
IV To evaluate the change in VEGF in the plasma and VEGFR-2 in the serum as circulating biomarkers after treatment with GW786034
V To evaluate the change in circulating tumor cells in peripheral blood after treatment with GW786034
VI To determine whether the steady-state plasma concentration of GW786034 correlates with inhibition of phosphorylated phospho-VEGFR-2 and other endpoints in breast tumor biopsies
VII To evaluate the change in vascular permeability by dynamic contrast enhanced DCE-magnetic resonance imaging MRI of the breast after treatment with GW786034
VIII To compare the images obtained with bilateral DCE-MRI of the breast before during and after treatment with GW786034
OUTLINE
Patients receive pazopanib hydrochloride orally PO once daily QD for 12-20 days in the absence of disease progression or unacceptable toxicity Patients then undergo surgical resection of tumor between days 13 and 21 24 hours after completion of pazopanib hydrochloride
After completion of study treatment patients are followed up within 30 days
I To determine the biologic effect measured by a decrease in phosphorylation of vascular endothelial growth factor receptor 2 VEGFR-2 andor decrease in microvessel density in breast tumor biopsies after treatment with daily oral GW786034 pazopanib hydrochloride for at least 12 consecutive days in early stage operable breast cancer or local andor regional recurrence that is amenable to surgery
II To determine the mechanism of antitumor effect measured by a reduction in tumor cell proliferation Ki67 or an increase in apoptosis in breast tumor biopsies after treatment with GW786034
SECONDARY OBJECTIVES
I To determine the change in levels of tissue vascular endothelial growth factor VEGF in breast tumor biopsies after treatment with GW786034
II To evaluate the change in phosphorylation of epidermal growth factor receptor EGFR mitogen-activated protein kinase MAPK and protein kinase B AKT in breast tumor biopsies after treatment with GW786034
III To identify gene expression patterns in breast tumor biopsies before and after treatment with GW786034
IV To evaluate the change in VEGF in the plasma and VEGFR-2 in the serum as circulating biomarkers after treatment with GW786034
V To evaluate the change in circulating tumor cells in peripheral blood after treatment with GW786034
VI To determine whether the steady-state plasma concentration of GW786034 correlates with inhibition of phosphorylated phospho-VEGFR-2 and other endpoints in breast tumor biopsies
VII To evaluate the change in vascular permeability by dynamic contrast enhanced DCE-magnetic resonance imaging MRI of the breast after treatment with GW786034
VIII To compare the images obtained with bilateral DCE-MRI of the breast before during and after treatment with GW786034
OUTLINE
Patients receive pazopanib hydrochloride orally PO once daily QD for 12-20 days in the absence of disease progression or unacceptable toxicity Patients then undergo surgical resection of tumor between days 13 and 21 24 hours after completion of pazopanib hydrochloride
After completion of study treatment patients are followed up within 30 days
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-2009-00183 | REGISTRY | None | None |
| CDR0000534258 | None | None | None |
| 040607 | None | None | None |
| 040607 | OTHER | None | None |
| 7529 | OTHER | None | None |
| U01CA132194 | NIH | None | None |
| P30CA072720 | NIH | CTEP | httpsreporternihgovquickSearchP30CA072720 |