Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047333
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2002-10-03
Brief Title:
Erlotinib in Treating Patients With Liver Cancer That Cannot be Surgically Removed
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Open-Label Study Of OSI-774 NSC 718781 In Unresectable Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of erlotinib in treating patients who have liver cancer that cannot be surgically removed Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess progression-free survival PFS measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma
SECONDARY OBJECTIVES
I To assess objective response rate rate and duration of stable disease time to progression median and overall survival in this patient population and any changes in tumor perfusion based on functional CT imaging
II To correlate response with patient characteristics including age disease stage TNM Okuda 6 viral hepatitis status pathologic grade of cirrhosis Childs-Pugh status Performance Status serum values of alpha feto-protein bilirubin transaminases albumin EGFR expression score by IHC and development of skin rash during therapy
III To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population
IV To determine the safety and tolerability of OSI-774 in this patient population
OUTLINE Patients are stratified according to epidermal growth factor receptor expression low 0-1 vs high 2-3
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
I To assess progression-free survival PFS measured at 16 weeks following initiation of once daily continuous oral therapy with OSI-774 in patients with unresectable hepatocellular carcinoma
SECONDARY OBJECTIVES
I To assess objective response rate rate and duration of stable disease time to progression median and overall survival in this patient population and any changes in tumor perfusion based on functional CT imaging
II To correlate response with patient characteristics including age disease stage TNM Okuda 6 viral hepatitis status pathologic grade of cirrhosis Childs-Pugh status Performance Status serum values of alpha feto-protein bilirubin transaminases albumin EGFR expression score by IHC and development of skin rash during therapy
III To determine the pharmacokinetic and pharmacodynamic profile of OSI-774 in this patient population
IV To determine the safety and tolerability of OSI-774 in this patient population
OUTLINE Patients are stratified according to epidermal growth factor receptor expression low 0-1 vs high 2-3
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000257665 | REGISTRY | PDQ Physician Data Query | None |
| ID02-008 | None | None | None |