Transarterial Chemoembolization Using Doxorubicin Beads With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. Sorafenib tosylate 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. It is not yet known whether transarterial chemoembolization using doxorubicin-eluting beads is more effective when given with or without sorafenib tosylate in treating patients with liver cancer that cannot be removed by surgery.

PURPOSE: This randomized phase III trial is studying giving transarterial chemoembolization using doxorubicin-eluting beads and sorafenib tosylate to see how well it works compared with giving transarterial chemoembolization using doxorubicin-eluting beads and a placebo in treating patients with liver cancer that cannot be removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Doxorubicin; Liposomal doxorubicin; Niacinamide; Sorafenib

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed hepatocellular carcinoma (HCC) OR meets the American Association for the Study of Liver Diseases (AASLD) criteria for diagnosis of HCC

• Unresectable disease

• Not amenable to liver transplantation

• At least one uni-dimensionally measurable lesion according to the RECIST criteria by CT scan or MRI

• Child-Pugh A (score ≤ 6) and no Child-Pugh cirrhosis C or B (score ≥ 7)

• No ascites refractory to diuretic therapy

• No documented occlusion of the hepatic artery or main portal vein

• No extrahepatic metastasis or hepatic encephalopathy

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Life expectancy > 3 months

• Hemoglobin ≥ 9 g/L

• Absolute neutrophil count ≥ 1.5 x 10^9/L

• Platelet count ≥ 60,000/μL

• Bilirubin ≤ 50 μmol/L

• Alkaline phosphatase < 4 times upper limit of normal (ULN)

• AST and ALT < 5 times ULN

• Creatinine ≤ 1.5 times ULN

• Amylase and lipase < 2 times ULN

• INR ≤ 1.5

• LVEF ≥ 45%

• Able to swallow oral medication

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during study and for 3 months after completion of study treatment

• No history of bleeding within the past 4 weeks

• No contraindications for hepatic embolization procedures, including portosystemic shunt, hepatofugal blood flow, or known severe atheromatosis

• No hypersensitivity to intravenous contrast agents

• No active clinically serious infection > grade 2 (NCI-CTC version 4)

• No known history of HIV infection

• No history of second malignancy except non-melanotic skin cancer or cervical carcinoma in situ or malignancy treated with curative intent with > 3 years without relapse

• No evidence of severe or uncontrolled disease including any of the following:

• Systemic disease

• Cardiac arrhythmias (requiring anti-arrhythmic therapy or pacemaker)

• Hypertension

• NYHA class III or IV congestive cardiac failure

• Myocardial infarction within the past 6 months

• Laboratory finding that, in the view of the Investigator, makes it undesirable for the patient to participate in the trial

• No psychiatric or other disorder likely to impact on informed consent

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior and no concurrent investigational therapy

• No prior embolization, systemic therapy, or radiotherapy for HCC

• No major surgery within the past 4 weeks

• No ablative therapy (radiofrequency ablation or percutaneous ethanol injection) for HCC

• Patients with untreated target lesion(s) and ablation occurred > 6 weeks prior to study entry allowed

• No concurrent rifampicin or St. John wort

• No concurrent bone marrow transplant or stem cell rescue

• No concurrent bevacizumab or drugs that target VEGF or VEGF receptors

• No other concurrent anticancer chemotherapy, immunotherapy, hormone therapy, or molecular therapy except bisphosphonates