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Epirubicin and Thalidomide in Treating Patients With Liver Cancer



Epirubicin and Thalidomide in Treating Patients With Liver Cancer

For Condition: adult primary hepatocellular carcinoma,advanced adult primary liver cancer,recurrent adult primary liver cancer,localized unresectable adult primary liver cancer
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AndrewZhu,  Study Chair,  Dana-Farber/Harvard Cancer Center

Massachusetts General Hospital Cancer Center *Recruiting*
Boston,  Massachusetts,  02114
United States
Recruiting Andrew  Zhu 617-724-0786

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston,  Massachusetts,  02114
United States
Recruiting Andrew  Zhu 617-724-0786


Additional Information:
Study ID Numbers:  CDR0000298783;  CELGENE-2001-P-00170/1,DFCI-01281
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058487

Other Localized Unresectable Adult Primary Liver Cancer Studies:
1. DX-8951f in Treating Patients With Liver Cancer

2. Sho-Saiko-To Following Removal of Liver Cancer By Embolization in Treating Patients With Liver Cancer That Cannot Be Surgically Removed

3. Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed

4. Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

5. Gemcitabine Plus Pemetrexed Disodium in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer

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