Chemoembolization Using Doxorubicin in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

OBJECTIVES:

• Determine, preliminarily, the feasibility of chemoembolization with GelSpheres™ beads mixed with doxorubicin hydrochloride in patients with unresectable hepatocellular carcinoma.

OUTLINE: This is a pilot study.

Patients undergo catheterization of the hepatic artery followed by chemoembolization comprising an infusion of GelSpheres™ beads mixed with doxorubicin hydrochloride into the target hepatic artery. Patients may receive up to 3 chemoembolization treatments.

After completion of study treatment, patients are followed at 1 month, every 2 months for 1 year, and then every 3 months during year 2.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of Liver (EASL) disease diagnostic criteria AND the Okuda staging classification

• No advanced disease, as defined by any of the following:

• Barcelona Clinic Liver Cancer (BCLC) class C disease, as defined by the following:

• Vascular invasion, including segmental portal obstruction
• Extrahepatic spread
• Cancer-related symptoms (PST of 1-2)
• BCLC class D disease, as defined by the following:

• Okuda stage III disease
• World Health Organization (WHO) performance status 3 or 4
• Diffuse HCC, defined as massive ill-defined tumor involvement
• Child-Pugh Class C
• Not eligible for radical therapies (e.g., resection, liver transplantation, or percutaneous therapies)
• No significant liver decompensation

• Preserved liver function (Child-Pugh class A-B)

• No ascites (trace ascites allowed)
• No other active primary tumor
• Arteries supplying the lesion must be large enough to accept GelSpheres™ beads

PATIENT CHARACTERISTICS:

• Bilirubin ≤ 3 mg/dL
• Albumin > 2.0 g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN)
• Alkaline phosphatase ≤ 5 times the upper limit of normal (ULN)
• No active gastrointestinal bleeding
• No encephalopathy
• No contraindication to hepatic embolization procedures, as indicated by any of the following:

• Porto-systemic shunt
• Hepatofugal blood flow
• Platelet count < 50,000/mm^3
• International normalized ratio (INR) ≥ 1.8
• Partial thromboplastin time (PTT) ≥ 39 seconds
• Renal failure
• Severe atheromatosis
• No contraindication to doxorubicin hydrochloride administration, as indicated by any of the following:

• Bilirubin > 5 mg/dL
• White blood cell (WBC) < 1,500/mm^3
• Ejection fraction < 50% by isotopic ventriculography or echocardiography
• Not pregnant
• No known allergy to contrast media
• No intolerance to occlusion procedures
• No vascular anatomy or bleeding that would preclude catheter placement or emboli injection, as indicated by any of the following:

• Active or risk of hemorrhage
• Patent extra-to-intracranial anastomoses or shunts
• End arteries leading directly to the cranial nerves
• Feeding arteries smaller than distal branches from which they emerge
• Collateral vessel pathways that would potentially endanger normal territories during embolization

PRIOR CONCURRENT THERAPY:

• No prior anticancer therapy for HCC