Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071994
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2003-11-04
Brief Title:
Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of ZD1839 Iressa Gefitinib NSC 715055 in Advanced Unresectable Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-02
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 gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma liver cancer Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the ability of ZD1839 to improve progression free survival in patients with advanced unresectable hepatocellular carcinoma
II Evaluate response rate of ZD1839 in advanced unresectable hepatocellular carcinoma
III Evaluate the effect of ZD1839 on measurable disease in patients with unresectable hepatocellular carcinoma
IV Evaluate the effect of ZD1839 on serum alpha-fetoprotein levels in patients with abnormal pretreatment serum levels
V Evaluate toxicity of ZD1839 in advanced unresectable hepatocellular carcinoma
VI Investigate biologic markers for outcome in patients with unresectable hepatocellular carcinoma treated with ZD1839
OUTLINE This is a multicenter study
Patients receive oral gefitinib daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 3 years from study entry
I Evaluate the ability of ZD1839 to improve progression free survival in patients with advanced unresectable hepatocellular carcinoma
II Evaluate response rate of ZD1839 in advanced unresectable hepatocellular carcinoma
III Evaluate the effect of ZD1839 on measurable disease in patients with unresectable hepatocellular carcinoma
IV Evaluate the effect of ZD1839 on serum alpha-fetoprotein levels in patients with abnormal pretreatment serum levels
V Evaluate toxicity of ZD1839 in advanced unresectable hepatocellular carcinoma
VI Investigate biologic markers for outcome in patients with unresectable hepatocellular carcinoma treated with ZD1839
OUTLINE This is a multicenter study
Patients receive oral gefitinib daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed for 3 years from study entry
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 |
|---|---|---|---|
| CDR0000335058 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA021115 |
| E1203 | None | None | None |
| U10CA021115 | NIH | None | None |