Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Liver Cancer Home Page 2 NCI's gateway for information about liver cancer. Extrahepatic Bile Duct Cancer Home Page 3 NCI's gateway for information about extrahepatic bile duct cancer.

Name of the Trial

Phase II Study of Lapatinib in Patients With Unresectable Hepatocellular Carcinoma or Biliary Tract Carcinoma (OSU-0447). See the protocol abstract ⁴.

Principal Investigator

Dr. Tanios Bekaii-Saab, Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University.

Why This Trial Is Important

Dr. Tanios Bekaii-Saab Principal Investigator

Hepatocellular carcinoma (liver cancer) and biliary tract carcinoma (cancer of the bile ducts) are rare in the United States; however, patients with these cancers face a bleak prognosis if their tumors cannot be surgically removed.

In this clinical trial, researchers are testing the ability of a new drug called lapatinib to delay tumor growth and possibly improve the survival of patients with inoperable hepatocellular or biliary tract cancer. Lapatinib works by disrupting chemical signals that stimulate the growth and spread of cancer cells. Specifically, this drug blocks the activity of two tyrosine kinases (proteins involved in cell communication) called EGFR and HER2, which are found in increased amounts on some types of cancer cells, including hepatocellular and biliary tract cancers.

"Lapatinib represents a new generation of targeted therapies in that it targets multiple proteins that affect the growth and metastatic potential of cancer cells," said Dr. Bekaii-Saab. "The EGFR and HER2 proteins may work in tandem in these tumors, so it makes sense to employ an agent that can effectively block the activity of both proteins.

"Patients with inoperable liver or biliary tract cancer have very few options available to them," Dr. Bekaii-Saab said. "We hope that lapatinib will offer these patients a new and more effective treatment choice than traditional chemotherapy."

Contact Information

This clinical trial is no longer accepting new patients. To locate other clinical trials for liver or biliary tract cancer, search the NCI's database of clinical trials ¹ or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is completely confidential.

Glossary Terms

The protein found on the surface of some cells and to which epidermal growth factor binds, causing the cells to divide. It is found at abnormally high levels on the surface of many types of cancer cells, so these cells may divide excessively in the presence of epidermal growth factor. Also called epidermal growth factor receptor, ErbB1, and HER1.

A protein involved in normal cell growth. It is found on some types of cancer cells, including breast and ovarian. Cancer cells removed from the body may be tested for the presence of HER2/neu to help decide the best type of treatment. HER2/neu is a type of receptor tyrosine kinase. Also called c-erbB-2, human EGF receptor 2, and human epidermal growth factor receptor 2.

A drug used with another anticancer drug to treat breast cancer that is HER2 positive and has advanced or metastasized (spread to other parts of the body) after treatment with other drugs. Lapatinib is also being studied in the treatment of other types of cancer. It is a type of ErbB-2 and EGFR dual tyrosine kinase inhibitor. Also called GW572016, lapatinib ditosylate, and Tykerb.

The likely outcome or course of a disease; the chance of recovery or recurrence.