Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information
Epirubicin and Thalidomide in Treating Patients With Liver Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Completed | Over 18 | NCI, Pharmaceutical / Industry | DFCI-01281 CELGENE-2001-P-00170/1, NCT00058487 |
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.
Entry Criteria
Disease Characteristics:
- Diagnosis of hepatocellular carcinoma
- Locally unresectable or metastatic disease
- Measurable disease
- No clinically apparent CNS metastases
- No carcinomatous meningitis
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
Patient Characteristics:
Age
- Over 18
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 75,000/mm3
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
Expected Enrollment
12A total of 12 patients per year will be accrued for this study.
Outcomes
Primary Outcome(s)Antitumor activity
Toxic effects
Outline
Patients receive epirubicin on days 1, 8, and 15 and thalidomide on days 1-21. Courses repeat every 28 days.
Published ResultsZhu AX, Fuchs CS, Clark JW, et al.: A phase II study of epirubicin and thalidomide in unresectable or metastatic hepatocellular carcinoma. Oncologist 10 (6): 392-8, 2005 Jun-Jul.[PUBMED Abstract]
Trial Lead Organizations
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 | | | |
| Andrew Zhu, MD, PhD, Protocol chair(Contact information may not be current) | |
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| Registry Information | ||
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| Official Title | A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma | |
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| Trial Start Date | 2001-12-01 | |
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| Registered in ClinicalTrials.gov | NCT00058487 | |
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| Date Submitted to PDQ | 2003-03-06 | |
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| Information Last Verified | 2006-10-16 | |
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| NCI Grant/Contract Number | P30-CA06516 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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