Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482625
Status:
TERMINATED
Last Update Posted:
2014-10-16
First Post:
2007-06-04
Brief Title:
Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IIA Trial Testing Erlotinib as an Intervention Against Intraductal Pancreatic Mucinous Neoplasms
Status:
TERMINATED
Status Verified Date:
2014-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The protocol has been completed prematurely eg due to poor accrual insufficient drug supply IND closure
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed This phase II trial is studying how well erlotinib hydrochloride works in treating patients with pancreatic cancer that can be removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I To test the hypothesis that the activated epidermal growth factor receptor EGFR signal transduction biomarker Mucin 5AC MUC5AC protein expression within intraductal pancreatic mucinous neoplasm IPMN lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib erlotinib hydrochloride administration at 100mg orally PO once daily QD
SECONDARY OBJECTIVES
I To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy
II Safety of Erlotinib treatment III To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mgday dose up to 42 days of therapy
OUTLINE
Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease progression or unacceptable toxicity Patients then undergo to pancreatectomy
After completion of study treatment patients are followed up at 4-20 weeks
I To test the hypothesis that the activated epidermal growth factor receptor EGFR signal transduction biomarker Mucin 5AC MUC5AC protein expression within intraductal pancreatic mucinous neoplasm IPMN lesions will have greater than zero absolute mean decrease from baseline comparing pre and post 21-42 days of Erlotinib erlotinib hydrochloride administration at 100mg orally PO once daily QD
SECONDARY OBJECTIVES
I To test the hypothesis that other correlative IPMN EGF inducible biomarkers will have greater than zero absolute mean decrease from baseline pre and post Erlotinib 100mg PO QD therapy
II Safety of Erlotinib treatment III To determine Erlotinib pharmacokinetic concentration in plasma and pancreatic tissue at the 100mgday dose up to 42 days of therapy
OUTLINE
Patients receive erlotinib hydrochloride PO QD for 21-42 days in the absence of disease progression or unacceptable toxicity Patients then undergo to pancreatectomy
After completion of study treatment patients are followed up at 4-20 weeks
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 |
|---|---|---|---|
| CDR0000547235 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CN35160 |
| UCI 06-30 | None | None | None |
| N01CN35160 | NIH | None | None |