Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101036
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2005-01-07
Brief Title:
Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver 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 of GW572016 Lapatanib in Locally Advanced or Metastatic Hepato-Biliary Cancers
Status:
COMPLETED
Status Verified Date:
2018-03
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 lapatinib works in treating patients with locally advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I The goal of this study is to determine the objective response rate of GW572016 in patients with biliary cancer and hepatocellular cancer HCC
SECONDARY OBJECTIVES
I Determine the overall survival of patients entered onto study II Quantitative and qualitative toxicities of the patient population treated with GW572016
III Determine the progression free survival of patients IV To perform molecular and pharmacogenomic correlative studies that will identify specific patient subsets that benefit from GW572016 therapy
OUTLINE This is a multicenter study Patients are stratified according to tumor site biliary tree cancer includes ampullary bile duct and gall bladder cancer vs hepatocellular cancer
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
I The goal of this study is to determine the objective response rate of GW572016 in patients with biliary cancer and hepatocellular cancer HCC
SECONDARY OBJECTIVES
I Determine the overall survival of patients entered onto study II Quantitative and qualitative toxicities of the patient population treated with GW572016
III Determine the progression free survival of patients IV To perform molecular and pharmacogenomic correlative studies that will identify specific patient subsets that benefit from GW572016 therapy
OUTLINE This is a multicenter study Patients are stratified according to tumor site biliary tree cancer includes ampullary bile duct and gall bladder cancer vs hepatocellular cancer
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
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 |
|---|---|---|---|
| N01CM62209 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62209 |
| NCI-2012-03065 | REGISTRY | None | None |
| PHII-53 | OTHER | None | None |
| 6674 | OTHER | None | None |
| N01CM62201 | NIH | None | None |