Epirubicin and Thalidomide in Treating Patients With Liver Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy such as epirubicin use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of hepatocellular (liver) cancer by stopping blood flow to the tumor. Combining epirubicin with thalidomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining epirubicin with thalidomide in treating patients who have unresectable or metastatic liver cancer.

Detailed Description
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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.

Official Title
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A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: epirubicin hydrochloride
* Drug: thalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: epirubicin hydrochloride|nan|
|Drug: thalidomide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumor activity |  |  | 
| Toxic effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer