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A Phase II Study of GW572016 (Lapatanib) in Locally Advanced or Metastatic Hepato-Biliary Cancers
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Start Date
November 1, 2004
Primary Completion Date
January 1, 2009
Completion Date
January 1, 2009
Last Updated
April 20, 2018
57
ACTUAL participants
lapatinib ditosylate
DRUG
laboratory biomarker analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT01730937
NCT02088775
Data Source & Attribution
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