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


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Safety Issue:

No

Principal Investigator

Andrew X. Zhu, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000298783

NCT ID:

NCT00058487

Start Date:

December 2001

Completion Date:

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115