Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00356889
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2006-07-26
Brief Title:
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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:
This phase II trial is studying how well giving bevacizumab together with erlotinib hydrochloride works in treating patients with metastatic or unresectable biliary tumors 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 Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Bevacizumab and erlotinib hydrochloride may also stop the growth of tumor cells by blocking blood flow to the tumor Giving bevacizumab together with erlotinib hydrochloride may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride
SECONDARY OBJECTIVES
I Evaluate time to progression in these patients
II Evaluate overall and progression-free survival of these patients
III Evaluate the adverse events associated with this regimen OUTLINE This is an open-label multicenter study
Patients receive bevacizumab intravenously IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
After completion of study therapy patients are followed periodically for up to 3 years
I Evaluate the objective response rate in patients with metastatic or unresectable cholangiocarcinoma treated with bevacizumab and erlotinib hydrochloride
SECONDARY OBJECTIVES
I Evaluate time to progression in these patients
II Evaluate overall and progression-free survival of these patients
III Evaluate the adverse events associated with this regimen OUTLINE This is an open-label multicenter study
Patients receive bevacizumab intravenously IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression
After completion of study therapy patients are followed periodically for up to 3 years
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 |
|---|---|---|---|
| N01CM17104 | NIH | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17104 |
| MC044G | None | None | None |
| CDR0000484566 | REGISTRY | None | None |