Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Trial ID or NCT#
This randomized phase III trial studies chemoembolization and sorafenib tosylate to see how well they work compared with chemoembolization alone in treating patients with liver cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as doxorubicin hydrochloride, mitomycin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumor and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemoembolization together with sorafenib tosylate is more effective than chemoembolization alone in treating patients with liver cancer.
A Phase III Randomized, Double-Blind Trial of Chemoembolization With or Without Sorafenib in Unresectable Hepatocellular Carcinoma (HCC) in Patients With and Without Vascular Invasion
- - Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below: - Histologically confirmed - Magnetic resonance imaging (MRI) or computerized tomography (CT) consistent with liver cirrhosis AND at least one solid liver lesion > 2 cm with early enhancement and delayed enhancement washout regardless of alpha-feto protein levels (AFP) - AFP > 400 ng/mL AND evidence of at least one solid liver lesion > 2 cm regardless of specific imaging characteristics on CT or MRI - Patients must have hepatocellular carcinoma (HCC) limited to the liver - Portal lymphadenopathy is permitted for patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) - as lymphadenopathy is commonly associated with hepatitis unrelated to malignancy - Staging CT of the chest and CT or MRI of the abdomen and pelvis must have been completed within 4 weeks of study registration - Patients must have measurable disease constituting < 50% of liver parenchyma within 4 weeks of registration - Patients may have been treated with RFA in the past, but no sooner than 4 weeks before study registration - Patients may have undergone previously attempted curative liver resection - Branch portal vein invasion by tumor is permitted - Patients must have Child-Pugh score of A or B7 within 4 weeks prior to study registration - Serum total bilirubin =< 2.0 mg/dL - Alkaline phosphatase < 5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST), alanine aminotransferase (ALT) < 5 x ULN - Serum creatinine =< 1.5 mg/dL - Platelet count >= 50,000/mm^3 - Patients must meet New York Heart Association functional classification I or II defined as: - Class I - patients with no limitation of activities; they suffer no symptoms from ordinary activities - Class II - patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion - Patients must have an ECOG performance status of 0 or 1 - Patients must have a life expectancy of at least 3 months - Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception - Patient must be able to swallow pills, as study medications cannot be crushed
- - Clinical or radiographic evidence of extrahepatic HCC - Ascites detectable on physical examination - Candidates for curative resection, orthotopic liver transplantation, or radiofrequency ablation (RFA) - Prior brachytherapy such as yttrium-90 microsphere - Prior sorafenib, chemoembolization, or systemic chemotherapy including cytotoxic agents or molecularly targeted agents - Patients with main portal vein invasion by tumor - Evidence of bleeding diathesis or active gastrointestinal bleeding - Clinical signs of heart failure - Human immunodeficiency virus (HIV) positive - Other uncontrolled intercurrent illnesses excluding HBV or HCV, including, but not limited to: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/addictive disorders that would limit compliance with study requirements - Uncontrolled hypertension is defined as optimally treated baseline blood pressure that exceeds 150/90 mm Hg - Patients must not be taking cytochrome P450 enzyme inducing drugs - Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy - Allergy to iodine or gadolinium contrast that cannot be safely controlled with premedication
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