Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335829
Status:
COMPLETED
Last Update Posted:
2021-08-13
First Post:
2006-06-08
Brief Title:
Bevacizumab and Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Phase II Trial of Bevacizumab Combined With Transarterial Chemoembolization TACE for Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2021-08
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 Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Chemoembolization kills tumor cells by carrying chemotherapy drugs directly into the tumor and blocking the blood flow to the tumor Giving bevacizumab together with chemoembolization may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving bevacizumab together with chemoembolization works in treating patients with liver cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy
Secondary
Characterize the safety and toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
OUTLINE Patients receive bevacizumab once in weeks 1 3 and 5 Beginning in week 3 patients also receive transarterial chemoembolization TACE therapy Treatment repeats approximately every 8 weeks for up to 3 courses Patients achieving 100 necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Improve median progression-free survival of patients with unresectable hepatocellular cancer treated with bevacizumab and transarterial chemoembolization therapy
Secondary
Characterize the safety and toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
OUTLINE Patients receive bevacizumab once in weeks 1 3 and 5 Beginning in week 3 patients also receive transarterial chemoembolization TACE therapy Treatment repeats approximately every 8 weeks for up to 3 courses Patients achieving 100 necrosis by MRI after the first course receive 2 additional courses of bevacizumab and TACE
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NA_00001249 | None | None | None |
| JHOC-J0598 | None | None | None |