Epirubicin and Thalidomide in Treating Patients With Liver Cancer

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058487
• Other study ID #: DFCI-01281
• Secondary ID: CDR0000298783CEL
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2003
• Last updated: July 17, 2013
• Start date: December 2001
• Est. completion date: January 2007

Study information

• Verified date: October 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• epirubicin hydrochloride

• thalidomide

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zhu AX, Fuchs CS, Clark JW, Muzikansky A, Taylor K, Sheehan S, Tam K, Yung E, Kulke MH, Ryan DP. A phase II study of epirubicin and thalidomide in unresectable or metastatic hepatocellular carcinoma. Oncologist. 2005 Jun-Jul;10(6):392-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor activity			No
Primary	Toxic effects			Yes