Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00524316
Status:
TERMINATED
Last Update Posted:
2017-05-09
First Post:
2007-08-31
Brief Title:
Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase II Study of SUNITINIB MALATE Sutent and Chemoembolization in Patients With Unresectable Hepatocellular Cancer
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs such as doxorubicin near the tumor Giving sunitinib together with chemoembolization may kill more tumor cells
PURPOSE This phase II trial is studying how well giving sunitinib together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving sunitinib together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
To determine the progression-free survival at 4 months of patients treated with this regimen
Secondary
To determine overall survival of these patients
To determine if dynamic contrast-enhanced magnetic resonance imaging DCE-MRI can be used to measure decrease in tumor perfusion and vascular permeability as a result of treatment with sunitinib malate in combination with TACE and if it can be useful in prognosis
To examine the safety and tolerability of this regimen
To determine if a change in circulating endothelial precursor cell number and total monocyte count on days 3 8 10 and 35 of therapy as compared with levels at baseline and decrease in soluble vascular endothelial growth factor receptor-2 in serum on days 8 before TACE 10 and 35 of therapy as compared with baseline correlate with improved response and survival
To determine the effect of this therapy on quality of life as measured by the FACT-HEP scale prior to each course of therapy
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses Patients undergo hepatic artery chemoembolization with doxorubicin hydrochloride on day 8 of course 1 only Treatment with sunitinib malate repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
NOTE Course 1 is 7 weeks in duration all subsequent courses are 6 weeks in duration
Blood samples are collected at baseline and periodically during study to measure circulating endothelial precursor cell levels total monocyte count and soluble vascular endothelial growth factor receptor-2
Quality of life is assessed by the FACT-HEP scale at baseline prior to each course of treatment and then at the completion of treatment
After completion of study treatment patients are followed every 6 months
Primary
To determine the progression-free survival at 4 months of patients treated with this regimen
Secondary
To determine overall survival of these patients
To determine if dynamic contrast-enhanced magnetic resonance imaging DCE-MRI can be used to measure decrease in tumor perfusion and vascular permeability as a result of treatment with sunitinib malate in combination with TACE and if it can be useful in prognosis
To examine the safety and tolerability of this regimen
To determine if a change in circulating endothelial precursor cell number and total monocyte count on days 3 8 10 and 35 of therapy as compared with levels at baseline and decrease in soluble vascular endothelial growth factor receptor-2 in serum on days 8 before TACE 10 and 35 of therapy as compared with baseline correlate with improved response and survival
To determine the effect of this therapy on quality of life as measured by the FACT-HEP scale prior to each course of therapy
OUTLINE This is a multicenter study
Patients receive oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses Patients undergo hepatic artery chemoembolization with doxorubicin hydrochloride on day 8 of course 1 only Treatment with sunitinib malate repeats every 6 weeks in the absence of disease progression or unacceptable toxicity
NOTE Course 1 is 7 weeks in duration all subsequent courses are 6 weeks in duration
Blood samples are collected at baseline and periodically during study to measure circulating endothelial precursor cell levels total monocyte count and soluble vascular endothelial growth factor receptor-2
Quality of life is assessed by the FACT-HEP scale at baseline prior to each course of treatment and then at the completion of treatment
After completion of study treatment patients are followed every 6 months
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 |
|---|---|---|---|
| RPCI-I-82706 | None | None | None |