Epirubicin and Thalidomide in Treating Patients With Liver Cancer
Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Cancer
Intervention: epirubicin hydrochloride (Drug); thalidomide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s): Andrew X. Zhu, MD, PhD, Study Chair, Affiliation: Dana-Farber Cancer Institute
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.
Clinical Details
Official title: A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma
Study design: Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Antitumor activityToxic effects
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2001
Last updated: July 17, 2013
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