The purpose of this study is to decide if a medicine that slows growth of new blood vessels can be give after the embolization procedure to prevent or delay new growth of blood vessels to tumors.
This is a single-center, open-label, non-randomized, prospective phase II trial. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Sunitinib malate (Sutent) at a dose of 37.5mg will be administered orally once daily on days 1-28 in a 42-day cycle. Treatment with Sutent will begin no sooner than seven days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks. No fewer than seven days shall separate treatment with Sutent and scheduling of hepatic artery embolizations.
1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor.
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Percentage of Participants With Progression Free Survival (PFS) at 12 Months
Kaplan-Meier analysis of PFS. Progression-free survival rate at 12 months after first embolization. PFS was defined as time from start of treatment until disease progression or death as a result of any cause. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Progressive Disease (PD): At least a 20% increase in the SLD of target lesions, taking as reference the smallest SLD recorded since the treatment started.
Time frame: 12 months
Percentage of Participants With Overall Survival (OS) at One Year
Overall survival at 12 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.
Time frame: 12 months
Number of Participants With Partial Radiographic Response
Objective radiographic response rate. Response and progression endpoints refer specifically to hepatic metastases. Extrahepatic metastases were included for assessment of response and progression by RECIST version 1.0. Partial Response (PR): At least a 30% decrease in the sum of longest diameter (SLD) of target lesions, taking as reference the baseline SLD.
Time frame: 12 months
Number of Participants With Biochemical Response
Biochemical response rate (\>50% reduction in tumor marker). Response and progression endpoints refer specifically to hepatic metastases.
Time frame: 12 months
Number of Participants Requiring Dose Reduction
Treatment related toxicity. Participants requiring dose reductions of sunitinib to 25 mg due to side effects.
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Time frame: 12 months
Percentage of Participants With Overall Survival (OS) at 4 Years
Participant overall survival at 48 months. OS was defined as time from start of treatment until death as a result of any cause, with patients censored at the date of last follow-up if still alive.
Time frame: 48 months