Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

Advanced Adult Primary Liver Cancer Clinical Trial

Official title: A Phase II Study of GW572016 (Lapatanib) in Locally Advanced or Metastatic Hepato-Biliary Cancers

Status Completed

Clinical Trial Summary

This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic biliary tract or liver cancer that cannot be removed by surgery. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. The goal of this study is to determine the objective response rate of GW572016 in patients with biliary cancer and hepatocellular cancer (HCC).

SECONDARY OBJECTIVES:

I. Determine the overall survival of patients entered onto study. II. Quantitative and qualitative toxicities of the patient population treated with GW572016.

III. Determine the progression free survival of patients. IV. To perform molecular and pharmacogenomic correlative studies that will identify specific patient subsets that benefit from GW572016 therapy.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor site (biliary tree cancer [includes ampullary, bile duct, and gall bladder cancer] vs hepatocellular cancer).

Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival. ;

Related Conditions & MeSH terms

• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Bile Duct Neoplasms
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Gallbladder Neoplasms
• Liver Neoplasms
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer
• Recurrent Extrahepatic Bile Duct Cancer
• Recurrent Gallbladder Cancer
• Unresectable Extrahepatic Bile Duct Cancer
• Unresectable Gallbladder Cancer

• NCT number: NCT00101036
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: November 2004
• Completion date: January 2009