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.
|Liver Cancer||Drug: doxorubicin hydrochloride Drug: sunitinib malate Other: laboratory biomarker analysis Procedure: hepatic artery embolization Procedure: quality-of-life assessment||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SUNITINIB MALATE (Sutent) and Chemoembolization in Patients With Unresectable Hepatocellular Cancer|
- Progression-free Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]median progression free survival in months
- Overall Survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]median survival in months
- 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 ]
- Safety and Tolerability [ Time Frame: Daily while on treatment through study completion, an average of 1 year ]
Number of participants with adverse advent.
Please refer to adverse event reporting for more detail.
- Assess the Change in the Quality of Life Among Patients Using the FACTHep (Version 4) for Hepatobiliary Cancers. [ Time Frame: Baseline and Cycle 2 ]
We utilized the FACT-HEP TOTAL SCORE (version 4) quality-of-life scale, which is a 45 item scale ranging from 96-178. Higher scores reflect better quality of life.
No subscales were analyzed.
- Tumor Marker Response (AFP) [ Time Frame: Baseline, week 7 and every 6 weeks after ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
|Study Start Date:||April 2007|
|Study Completion Date:||May 2014|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
oral sunitinib malate once daily on days 1-7 and 15-35 in course 1 and on days 1-28 in all subsequent courses
Drug: doxorubicin hydrochloride
Transarterial chemoembolizationDrug: sunitinib malate
Given OrallyOther: laboratory biomarker analysis
Correlative StudyProcedure: hepatic artery embolization
Surgical procedureProcedure: quality-of-life assessment
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524316
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Renuka Iyer, MD||Roswell Park Cancer Institute|