Epirubicin and Thalidomide in Treating Patients With Liver Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
First received: April 7, 2003
Last updated: July 17, 2013
Last verified: October 2006

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 Intervention Phase
Liver Cancer
Drug: epirubicin hydrochloride
Drug: thalidomide
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • Toxic effects [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: December 2001
Study Completion Date: January 2007
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

ClinicalTrials.gov Identifier: NCT00058487     History of Changes
Other Study ID Numbers: DFCI-01281  CDR0000298783  CELGENE-2001-P-00170/1 
Study First Received: April 7, 2003
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

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
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Leprostatic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on February 11, 2016