Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058487
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-04-07
Brief Title:
Epirubicin and Thalidomide in Treating Patients With Liver Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of Epirubicin And Thalidomide In Unresectable Or Metastatic Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CELGENE-2001-P-001701 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000298783 | REGISTRY | None | None |