Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049322
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2002-11-12
Brief Title:
Chemoembolization and Bevacizumab in Treating Patients With Liver Cancer That Cannot Be Removed With Surgery
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study Of rhuMAb VEGF BEVACIZUMAB In Patients With Hepatocellular Carcinoma Receiving Chemoembolization
Status:
COMPLETED
Status Verified Date:
2016-02
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 liposomal doxorubicin cisplatin and mitomycin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping the cells from dividing Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor Monoclonal antibodies such as bevacizumab can kill any tumor cells that are left after chemoembolization by blocking their ability to grow and spread
PURPOSE This randomized phase II trial is studying to see if chemoembolization followed by bevacizumab works better than chemoembolization alone in treating patients who have liver cancer that cannot be removed with surgery
PURPOSE This randomized phase II trial is studying to see if chemoembolization followed by bevacizumab works better than chemoembolization alone in treating patients who have liver cancer that cannot be removed with surgery
Detailed Description:
OBJECTIVES
Compare neovessel formation at 8 and 14 weeks after hepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma treated with bevacizumab versus no bevacizumab observation after chemoembolization only
Compare time to progression objective response rate and tumor marker progression in patients treated with these regimens
Determine the pharmacokinetics of bevacizumab in patients with liver function impairment
Determine the toxic effects of this drug in these patients
Compare the cancer biomarker pattern of peripheral blood cells and plasma before and after chemoembolization in patients treated with these regimens
OUTLINE This is a randomized open-label study
All patients receive hepatic artery chemotherapy chemoembolization comprising doxorubicin HCl liposome cisplatin and mitomycin on day 8 and possibly on day 92 Patients are then randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients do not receive bevacizumab Patients in arm II may cross-over receive bevacizumab as in arm I if recurrent tumor is evident at week 14 by CT scan or MRI or a 50 or greater increase in AFP level has occurred since day 8 chemoembolization
PROJECTED ACCRUAL A total of 30 patients 15 per treatment arm will be accrued for this study
Compare neovessel formation at 8 and 14 weeks after hepatic arterial chemoembolization in patients with unresectable hepatocellular carcinoma treated with bevacizumab versus no bevacizumab observation after chemoembolization only
Compare time to progression objective response rate and tumor marker progression in patients treated with these regimens
Determine the pharmacokinetics of bevacizumab in patients with liver function impairment
Determine the toxic effects of this drug in these patients
Compare the cancer biomarker pattern of peripheral blood cells and plasma before and after chemoembolization in patients treated with these regimens
OUTLINE This is a randomized open-label study
All patients receive hepatic artery chemotherapy chemoembolization comprising doxorubicin HCl liposome cisplatin and mitomycin on day 8 and possibly on day 92 Patients are then randomized to 1 of 2 treatment arms
Arm I Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients do not receive bevacizumab Patients in arm II may cross-over receive bevacizumab as in arm I if recurrent tumor is evident at week 14 by CT scan or MRI or a 50 or greater increase in AFP level has occurred since day 8 chemoembolization
PROJECTED ACCRUAL A total of 30 patients 15 per treatment arm 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 |
|---|---|---|---|
| NCI-G02-2124 | OTHER | NCI | None |
| UCLA-0206060 | OTHER | None | None |