Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00071994
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.
Study:
NCT00071994
Study Brief:
Protocol Section:
NCT00071994