A Phase II Study of SUNITINIB MALATE (Sutent) and Chemoembolization in Patients With Unresectable Hepatocellular Cancer
- To determine the response rate (complete, partial, and minimal response) in patients
with unresectable hepatocellular carcinoma treated with sunitinib malate in combination
with transarterial chemoembolization (TACE).
- To determine the progression-free survival at 4 months of patients treated with this
- 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
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate as measured by dynamic contrast-enhanced (DCE) CT scans
Baseline, day 8, day 10, day28, day 35
Renuka Iyer, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|