Epirubicin and Thalidomide in Treating Patients With Liver Cancer

OBJECTIVES:

• Determine the antitumor activity of epirubicin and thalidomide in patients with locally unresectable or metastatic hepatocellular carcinoma.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive epirubicin on days 1, 8, and 15 and thalidomide on days 1-21. Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 12 patients per year will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma

• Locally unresectable or metastatic disease
• Measurable disease
• No clinically apparent CNS metastases
• No carcinomatous meningitis

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 75,000/mm^3

Hepatic

• SGOT no greater than 5 times upper limit of normal
• Bilirubin no greater than 3.0 mg/dL
• INR no greater than 1.5*
• Albumin at least 2.0 g/dL NOTE: *Not required for patients receiving full anticoagulation with warfarin for deep vein thrombosis or pulmonary embolism

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 6 months
• LVEF normal by echocardiogram or MUGA

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Willing and able to participate in the System for Thalidomide Education and Prescribing Safety (STEPS) program
• No uncontrolled serious medical or psychiatric illness
• No other concurrent uncontrolled malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No more than 1 prior chemotherapy regimen for hepatocellular carcinoma
• No prior chemoembolization to the liver

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• More than 2 weeks since prior major surgery