Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Epirubicin and Thalidomide in Treating Patients With Liver Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	Over 18	NCI, Pharmaceutical / Industry	DFCI-01281 CELGENE-2001-P-00170/1, NCT00058487

Objectives

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

Entry Criteria

Disease Characteristics:

• Diagnosis of hepatocellular carcinoma
  • Locally unresectable or metastatic disease



• Measurable disease



• No clinically apparent CNS metastases



• No carcinomatous meningitis

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

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 75,000/mm³

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

Expected Enrollment

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

Outcomes

Antitumor activity
Toxic effects

Outline

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

Zhu AX, Fuchs CS, Clark JW, et al.: A phase II study of epirubicin and thalidomide in unresectable or metastatic hepatocellular carcinoma. Oncologist 10 (6): 392-8, 2005 Jun-Jul.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Andrew Zhu, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 617-632-3474; 866-790-4500

Registry Information
Official Title		A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma
Trial Start Date		2001-12-01
Registered in ClinicalTrials.gov		NCT00058487
Date Submitted to PDQ		2003-03-06
Information Last Verified		2006-10-16
NCI Grant/Contract Number		P30-CA06516

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