Sunitinib and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
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.
Drug: doxorubicin hydrochloride
Drug: sunitinib malate
Other: laboratory biomarker analysis
Procedure: hepatic artery embolization
Procedure: quality-of-life assessment
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SUNITINIB MALATE (Sutent) and Chemoembolization in Patients With Unresectable Hepatocellular Cancer|
- Response rate as measured by dynamic contrast-enhanced (DCE) CT scans [ Time Frame: Baseline, day 8, day 10, day28, day 35 ] [ Designated as safety issue: No ]
- Progression-free survival at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 6 months after removal from treatment till death ] [ Designated as safety issue: No ]
- Tissue perfusion, Ktrans, IAUC, and percent viable tumor as measured by DCE-MRI at baseline and on days 8 (before transarterial chemoembolization), 10, and 35 [ Time Frame: Baseline, day 8, day 10, day 28 and day 35 ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: Daily while on treatment ] [ Designated as safety issue: Yes ]
- Quality of life as measured by the FACT-HEP scale prior to each course of therapy [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
- Tumor marker response (AFP) [ Time Frame: Baseline, week 7 and every 6 weeks after ] [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: doxorubicin hydrochloride
- 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 regimen.
- 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.
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Renuka Iyer, MD||Roswell Park Cancer Institute|