Epirubicin and Thalidomide in Treating Patients With Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058487
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : July 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Liver Cancer Drug: epirubicin hydrochloride Drug: thalidomide Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma
Study Start Date : December 2001
Actual Study Completion Date : January 2007

Primary Outcome Measures :
  1. Antitumor activity
  2. Toxic effects

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of hepatocellular carcinoma

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



  • Over 18

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


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


  • 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


  • Creatinine no greater than 2.0 mg/dL


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


  • 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


Biologic therapy

  • Not specified


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

Endocrine therapy

  • Not specified


  • Not specified


  • More than 2 weeks since prior major surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058487

United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Study Chair: Andrew X. Zhu, MD, PhD Dana-Farber Cancer Institute

Publications of Results: Identifier: NCT00058487     History of Changes
Other Study ID Numbers: DFCI-01281
CDR0000298783 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: October 2006

Keywords provided by National Cancer Institute (NCI):
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action