Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375310
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2006-09-11
Brief Title:
Phase I Study of Gemcitabine Sorafenib and Radiotherapy in Patients With Unresectable Pancreatic Cancer
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Phase I Study of Gemcitabine With Novel RAF Kinase-Vascular Endothelial Growth Factor Receptor Inhibitor Sorafenib BAY 43-9006 and Radiotherapy in Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2016-02
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:
The purpose of this study is to evaluate the safety and tolerability of the combined treatment of Sorafenib BAY 43-9006 with Gemcitabine and radiotherapy in patients with localized unresectable pancreatic cancer
Detailed Description:
Pancreatic cancer treatment is hampered by its resistance to both chemo and radiotherapy Gemcitabine-based chemoradiotherapy has become one of the standard therapies for localized unresectable pancreatic cancer but with poor responses and survival rates of less than 12 months Radiotherapy increases VEGF expression and activates the RasMEKERK pathway which may contribute to radioresistance thus the addition of anti-angiogenic agents andor RasERK inhibitors could enhance radiation mediated cytotoxicity Sorafenib is a novel dual-action Raf kinase and vascular endothelial growth factor receptors VEGF-R2 and VEGF-R3 inhibitor targeting both angiogenic and Ras-Raf-1 signal transduction pathways Based upon preliminary laboratory and clinical data Sorafenib holds promise for improving outcomes of therapy for patients with locally advanced unresectable pancreatic cancer
Polymorphisms in genes involved in the angiogenesis pathway VEGF VEGF-R2 HIF-1 and eNOS may contribute to the process of angiogenesis tumor behavior and may explain the heterogeneity in efficacy and toxicity of agents whose major mechanism of action is blocking angiogenesis33-37 Proteomic analysis may also contribute to identify patterns of response or resistance to therapies and potentially predict outcomes
Dynamic contrast enhanced DCE-MRI has been shown to be a useful pharmacodynamic marker of biological activity for anti-angiogenic agents38-40 and may also predict radiation therapy-induced vascular changes41 In vivo imaging of angiogenesis using DCE-MRI and the analysis of angiogenesis markers genetic polymorphisms may predict response and clinical benefit to therapy for unresectable pancreatic cancer patients These biologic and pharmacodynamic endpoints will be analysed to correlate with the tumor activity seen
Polymorphisms in genes involved in the angiogenesis pathway VEGF VEGF-R2 HIF-1 and eNOS may contribute to the process of angiogenesis tumor behavior and may explain the heterogeneity in efficacy and toxicity of agents whose major mechanism of action is blocking angiogenesis33-37 Proteomic analysis may also contribute to identify patterns of response or resistance to therapies and potentially predict outcomes
Dynamic contrast enhanced DCE-MRI has been shown to be a useful pharmacodynamic marker of biological activity for anti-angiogenic agents38-40 and may also predict radiation therapy-induced vascular changes41 In vivo imaging of angiogenesis using DCE-MRI and the analysis of angiogenesis markers genetic polymorphisms may predict response and clinical benefit to therapy for unresectable pancreatic cancer patients These biologic and pharmacodynamic endpoints will be analysed to correlate with the tumor activity seen
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