Advanced Adult Primary Liver Cancer Clinical Trial
Official title:
A Phase II Study of ZD1839 (Iressa, Gefitinib, NSC 715055) in Advanced Unresectable Hepatocellular Carcinoma
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
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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