Clinical Trials Directory

Trials / Completed

CompletedNCT00071994

Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)

A Phase II Study of ZD1839 (Iressa, Gefitinib, NSC 715055) in Advanced Unresectable Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
59 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGgefitinibGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2004-02-01
Primary completion
2005-05-01
First posted
2003-11-06
Last updated
2013-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00071994. Inclusion in this directory is not an endorsement.