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Epirubicin and Thalidomide in Treating Patients With Liver Cancer

Primary Purpose

Liver Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epirubicin hydrochloride
thalidomide
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Outcomes

Primary Outcome Measures

Antitumor activity
Toxic effects

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
July 17, 2013
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058487
Brief Title
Epirubicin and Thalidomide in Treating Patients With Liver Cancer
Official Title
A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epirubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Antitumor activity
Title
Toxic effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew X. Zhu, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15967833
Citation
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.
Results Reference
result

Learn more about this trial

Epirubicin and Thalidomide in Treating Patients With Liver Cancer

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