Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047346
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2002-10-03
Brief Title:
Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose-Finding Safety And Pharmacokinetic Study Of The Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor OSI-774 NSC 718781 In Patients With Unresectable Hepatocellular Carcinoma And Moderate Hepatic Dysfunction
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of erlotinib in treating patients who have unresectable liver cancer and liver dysfunction Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Establish the maximum tolerated dose MTD and dose-limiting toxicity DLT of OSI-774 in patients with unresectable hepatocellular carcinoma HCC with moderate liver dysfunction
II Establish the pharmacokinetic and pharmacodynamic profile of OSI-774 in HCC patients with moderate liver dysfunction
SECONDARY OBJECTIVES
I Assess possible anti-tumor effects of OSI-774 in patients with advanced hepatocellular carcinoma in terms of partial response PR and complete response CR as assessed by tumor shrinkage by RECIST criteria
OUTLINE This is a dose-escalation study
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
I Establish the maximum tolerated dose MTD and dose-limiting toxicity DLT of OSI-774 in patients with unresectable hepatocellular carcinoma HCC with moderate liver dysfunction
II Establish the pharmacokinetic and pharmacodynamic profile of OSI-774 in HCC patients with moderate liver dysfunction
SECONDARY OBJECTIVES
I Assess possible anti-tumor effects of OSI-774 in patients with advanced hepatocellular carcinoma in terms of partial response PR and complete response CR as assessed by tumor shrinkage by RECIST criteria
OUTLINE This is a dose-escalation study
Patients receive oral erlotinib once daily Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| ID01-510 | None | None | None |
| U01CA062461 | NIH | None | None |
| CDR0000257666 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |