Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464919
Status:
COMPLETED
Last Update Posted:
2009-07-07
First Post:
2007-04-23
Brief Title:
Sorafenib Plus TegafurUracil UFUR for Hepatocellular Carcinoma HCC
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Phase II Study of Sorafenib Plus TegafurUracil for the Treatment of Advanced or Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2009-06
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:
The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma HCC is poor The role of conventional systemic chemotherapy has been very limited because most chemotherapeutic agents are in-effective and relative toxic to HCC patients who tend to have poor organ function reserves due to liver cirrhosis The molecular-targeted therapy which aims at deranged signaling pathways of cancer cells or their microenvironment holds promise for HCC
Sorafenib BAY 43-9006 a novel bi-aryl urea is a potent inhibitor of VEGFR2 and Raf kinase The clinical activity of sorafenib in HCC has been tested in a phase II study Bayer study 10874 which enrolled a total of 137 advanced HCC patients There were 4 of documented partial response 5 of minor response and 55 of stable disease The 6- month progression -free for the cohort was 40 Currently there are two on-going large-scale randomized trials of sorafenib in advanced HCC patients worldwide
Sorafenib BAY 43-9006 a novel bi-aryl urea is a potent inhibitor of VEGFR2 and Raf kinase The clinical activity of sorafenib in HCC has been tested in a phase II study Bayer study 10874 which enrolled a total of 137 advanced HCC patients There were 4 of documented partial response 5 of minor response and 55 of stable disease The 6- month progression -free for the cohort was 40 Currently there are two on-going large-scale randomized trials of sorafenib in advanced HCC patients worldwide
Detailed Description:
The prognosis for patients with metastatic or locally advanced hepatocellular carcinoma HCC is poor The role of conventional systemic chemotherapy has been very limited because most chemotherapeutic agents are in-effective and relative toxic to HCC patients who tend to have poor organ function reserves due to liver cirrhosis The molecular-targeted therapy which aims at deranged signaling pathways of cancer cells or their microenvironment holds promise for HCC
Sorafenib BAY 43-9006 a novel bi-aryl urea is a potent inhibitor of VEGFR2 and Raf kinase The clinical activity of sorafenib in HCC has been tested in a phase II study Bayer study 10874 which enrolled a total of 137 advanced HCC patients There were 4 of documented partial response 5 of minor response and 55 of stable disease The 6- month progression -free for the cohort was 40 Currently there are two on-going large-scale randomized trials of sorafenib in advanced HCC patients worldwideIn this study proposal we propose to combine sorafenib with metronomic chemotherapy in the treatment of advanced HCC patients It has been recently demonstrated that cytotoxic chemotherapy when given in a low-dose continuous and uninterrupted way ie the metronomic chemotherapy inhibits tumor angiogenesis The anti-angiogenesis effect of metronomic chemotherapy can be potentiated by combining the inhibitors of VEGFVEGFR pathway UFUR a composite drug composed of tegafur and uracil is an orally active 5-fluorouracil 5-FU preparation The activity of tegafururacil in HCC has been tested in two relatively small-scale phase II studies with objective tumor response rates ranging from 018 Interestingly tegafur and its metabolites including γ-hydroxybutyric acid and γ-butyrolactone have been shown to be potent inhibitors of angiogenesis in several preclinical models Therefore tegafururacil UFUR which has potential anti-HCC activity and interesting anti-angiogenesis activity is an ideal candidate drug to improve the efficacy of sorafenib in HCC
Sorafenib BAY 43-9006 a novel bi-aryl urea is a potent inhibitor of VEGFR2 and Raf kinase The clinical activity of sorafenib in HCC has been tested in a phase II study Bayer study 10874 which enrolled a total of 137 advanced HCC patients There were 4 of documented partial response 5 of minor response and 55 of stable disease The 6- month progression -free for the cohort was 40 Currently there are two on-going large-scale randomized trials of sorafenib in advanced HCC patients worldwideIn this study proposal we propose to combine sorafenib with metronomic chemotherapy in the treatment of advanced HCC patients It has been recently demonstrated that cytotoxic chemotherapy when given in a low-dose continuous and uninterrupted way ie the metronomic chemotherapy inhibits tumor angiogenesis The anti-angiogenesis effect of metronomic chemotherapy can be potentiated by combining the inhibitors of VEGFVEGFR pathway UFUR a composite drug composed of tegafur and uracil is an orally active 5-fluorouracil 5-FU preparation The activity of tegafururacil in HCC has been tested in two relatively small-scale phase II studies with objective tumor response rates ranging from 018 Interestingly tegafur and its metabolites including γ-hydroxybutyric acid and γ-butyrolactone have been shown to be potent inhibitors of angiogenesis in several preclinical models Therefore tegafururacil UFUR which has potential anti-HCC activity and interesting anti-angiogenesis activity is an ideal candidate drug to improve the efficacy of sorafenib in HCC
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