Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478140
Status:
TERMINATED
Last Update Posted:
2019-08-20
First Post:
2007-05-23
Brief Title:
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Trastuzumab NSC 688097 in Her2Neu Positive Cancer of the Gallbladder or Biliary Tract NCI 7756
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow accrual
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 trastuzumab works in treating patients with locally advanced or metastatic gallbladder cancer or bile duct cancer that cannot be removed by surgery Monoclonal antibodies such as trastuzumab 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
Detailed Description:
PRIMARY OBJECTIVE
I Determine the objective response rate and duration of objective response in patients with HER2neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab Herceptin
SECONDARY OBJECTIVES
I Assess the safety and tolerability of this drug in these patients II Assess the progression-free survival and overall survival of patients treated with this drug
OUTLINE
Patients receive trastuzumab intravenously over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
I Determine the objective response rate and duration of objective response in patients with HER2neu-positive advanced gallbladder or biliary tract cancer treated with trastuzumab Herceptin
SECONDARY OBJECTIVES
I Assess the safety and tolerability of this drug in these patients II Assess the progression-free survival and overall survival of patients treated with this drug
OUTLINE
Patients receive trastuzumab intravenously over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
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 |
|---|---|---|---|
| 2006-0851 | None | None | None |
| N01CM62202 | NIH | None | httpsreporternihgovquickSearchN01CM62202 |