Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00945477
Status:
TERMINATED
Last Update Posted:
2013-11-18
First Post:
2009-07-22
Brief Title:
Pazopanib as Second Line Therapy in Patients With Metastatic Prostate Cancer Refractory to Total Androgen Blockade
Sponsor:
Illinois CancerCare PC
Organization:
Illinois CancerCare PC
Study Overview
Official Title:
A Study of Pazopanib as Second Line Therapy in Patients With Metastatic Prostate Cancer Who Have Received Prior Therapy With an LHRH Agonist
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A growing body of literature supports the role of angiogenesis in the development and spread of a variety of human cancers including prostate cancer
Vascular endothelial growth factor VEGF expression is low in normal prostate tissue but markedly increased in tumor tissues and has a positive association with tumor stage and grade
Plasma VEGF levels are significantly elevated in patients with hormone refractory prostate cancer HRPC compared to those patients with localized disease and have been associated with disease progression in other cancer patient population
The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival
Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors
Vascular endothelial growth factor VEGF expression is low in normal prostate tissue but markedly increased in tumor tissues and has a positive association with tumor stage and grade
Plasma VEGF levels are significantly elevated in patients with hormone refractory prostate cancer HRPC compared to those patients with localized disease and have been associated with disease progression in other cancer patient population
The Cancer and Leukemic Group-B demonstrated that VEGF levels correlate with survival
Pazopanib is a potent multi-target receptor tyrosine kinase inhibitor of vascular endothelial growth factor receptors
Detailed Description:
VEGF expression is low in all normal prostate tissue but markedly increased in tumor tissue and has a positive association with MVD micro vessel density tumor stage grade and disease-specific survival in patients with prostate cancer VEGF is known to be under the influence of HIF-1α which is also up-regulated in the majority of prostate cancer tissue It has been shown that complete androgen blockade down-regulates VEGF expression via the HIF-1α pathway with concomitant up-regulation of thrombospondin and induction of endothelial cell apoptosis The VEGF pathway appears to be the dominant vascular formation pathway in prostate cancer with bFGF having a lesser role
Pazopanib a hydrochloride salt is a small molecule inhibitor of several tyrosine kinases ie VEGF 1 2 3 c-KIT and platelet-derived growth factor receptors The broad blockade of the VEGF receptors should interfere with the VEGFVEGF-receptor pathway and have an impact on cell growth
According to the NCCN guidelines first line therapy for metastatic prostate cancer is considered total androgen blockade either utilizing orchiectomy andor LHRH agonists plus Casodex
Second line therapy would depend on the patients response to first line therapy urgency of a response and the location of metastatic disease
Pazopanib has been explored in several settings It has recently been looked at with Bicalutamide in hormone refractory prostate cancer The second study was with earlier disease ie D-0 relapse androgen-sensitive patients The University of Chicago has a study looking at the sub-population of prostate cancer patients that have a chemical relapse in which patients are given one shot of Lupron and if the PSA is adequately suppressed the patients are randomized between pazopanib and placebo
Pazopanib a hydrochloride salt is a small molecule inhibitor of several tyrosine kinases ie VEGF 1 2 3 c-KIT and platelet-derived growth factor receptors The broad blockade of the VEGF receptors should interfere with the VEGFVEGF-receptor pathway and have an impact on cell growth
According to the NCCN guidelines first line therapy for metastatic prostate cancer is considered total androgen blockade either utilizing orchiectomy andor LHRH agonists plus Casodex
Second line therapy would depend on the patients response to first line therapy urgency of a response and the location of metastatic disease
Pazopanib has been explored in several settings It has recently been looked at with Bicalutamide in hormone refractory prostate cancer The second study was with earlier disease ie D-0 relapse androgen-sensitive patients The University of Chicago has a study looking at the sub-population of prostate cancer patients that have a chemical relapse in which patients are given one shot of Lupron and if the PSA is adequately suppressed the patients are randomized between pazopanib and placebo
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