Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033462
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2002-04-09
Brief Title:
Erlotinib in Treating Patients With Unresectable Liver Bile Duct or Gallbladder Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of OSI-774 in Patients With Hepatocellular or Biliary Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver bile duct or gallbladder cancer Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the proportion of patients with unresectable hepatocellular or biliary carcinoma treated with OSI-774 who are progression-free at 24 weeks
SECONDARY OBJECTIVES
I To evaluate the toxicity profile of this treatment in each of the patient groups
II To evaluate the objective response rate of patients with hepatocellular or biliary carcinoma treated with OSI-774
III To evaluate overall and progression-free survival IV To assess the EGFR protein levels and explore their association with clinical outcome
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 groups according to cancer type hepatocellular vs biliary
Patients receive oral erlotinib once daily Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for up to 3 years
I To evaluate the proportion of patients with unresectable hepatocellular or biliary carcinoma treated with OSI-774 who are progression-free at 24 weeks
SECONDARY OBJECTIVES
I To evaluate the toxicity profile of this treatment in each of the patient groups
II To evaluate the objective response rate of patients with hepatocellular or biliary carcinoma treated with OSI-774
III To evaluate overall and progression-free survival IV To assess the EGFR protein levels and explore their association with clinical outcome
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 groups according to cancer type hepatocellular vs biliary
Patients receive oral erlotinib once daily Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for up to 3 years
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 |
|---|---|---|---|
| MC0152 | None | None | None |
| 5429 | None | None | None |
| N01CM17104 | NIH | None | httpsreporternihgovquickSearchN01CM17104 |