Epirubicin and Thalidomide in Treating Patients With Liver Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma|
- Antitumor activity [ Designated as safety issue: No ]
- Toxic effects [ Designated as safety issue: Yes ]
|Study Start Date:||December 2001|
|Study Completion Date:||January 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00058487
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Andrew X. Zhu, MD, PhD||Dana-Farber Cancer Institute|