Epirubicin and Thalidomide in Treating Patients With Liver Cancer

NCT ID: NCT00058487

Last Updated: 2013-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-12-31
• Study Completion Date: 2007-01-31

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.

Detailed 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.

Conditions

Liver Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

epirubicin hydrochloride

Intervention Type: DRUG

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Andrew X. Zhu, MD, PhD

Role: STUDY_CHAIR

Dana-Farber Cancer Institute

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

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

Boston, Massachusetts, United States

Countries

United States

References

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. doi: 10.1634/theoncologist.10-6-392.

Reference Type: RESULT

PMID: 15967833 (View on PubMed)

Other Identifiers

CDR0000298783

Identifier Type: REGISTRY

Identifier Source: secondary_id

CELGENE-2001-P-00170/1

Identifier Type: -

Identifier Source: secondary_id

DFCI-01281

Identifier Type: -

Identifier Source: org_study_id