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 at http://cancer.gov/clinicaltrials/OSU-0447.

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

Why This Trial Is Important
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."

Who Can Join This Trial
Researchers seek to enroll 50 patients aged 18 and over with hepatocellular carcinoma or biliary tract carcinoma that cannot be surgically removed. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/OSU-0447.

Study Site and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study sites and contacts at http://www.cancer.gov/clinicaltrials/OSU-0447 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is completely confidential.