Epirubicin and Thalidomide in Treating Patients With Liver Cancer

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Liver Cancer

Treatments

Drug: epirubicin hydrochloride

Drug: thalidomide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00058487

DFCI-01281

CDR0000298783 (Registry Identifier)

CELGENE-2001-P-00170/1

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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