Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)

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Trial Identification

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

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

Study ID: NCT00071994

Conditions

Adult Primary Hepatocellular Carcinoma

Advanced Adult Primary Liver Cancer

Localized Unresectable Adult Primary Liver Cancer

Recurrent Adult Primary Liver Cancer

Interventions

gefitinib

laboratory biomarker analysis

Study Description

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.