Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT00071994
Status:
COMPLETED
Last Update Posted:
2013-02-27
First Post:
2003-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| E1203 | None | None | View | |
| U10CA021115 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDR0000335058 | REGISTRY | PDQ (Physician Data Query) | View |