Epirubicin and Thalidomide in Treating Patients With Liver Cancer - Full Text View

Sponsor:	Dana-Farber Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00058487

Purpose

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.

Condition	Intervention	Phase
Liver Cancer	Drug: epirubicin hydrochloride Drug: thalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Thalidomide Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Antitumor activity [ Designated as safety issue: No ]
Toxic effects [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	December 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058487

Locations

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Dana-Farber Cancer Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Andrew X. Zhu, MD, PhD

Dana-Farber Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000298783, DFCI-01281, CELGENE-2001-P-00170/1
Study First Received:	April 7, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00058487 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult primary hepatocellular carcinoma
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
recurrent adult primary liver cancer

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Thalidomide
Immunologic Factors
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Liver Neoplasms
Anti-Bacterial Agents
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Epirubicin
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009