Name of the Trial
Phase II Study of Doxorubicin and Bortezomib in Patients with Hepatocellular Carcinoma (ECOG-E6202). See the protocol abstract at http://cancer.gov/clinicaltrials/ECOG-E6202.

Principal Investigators
Dr. Jordan Berlin, Dr. Bruce Giantonio, and Dr. William Chapman, Eastern Cooperative Oncology Group

Why Is This Trial Important?
Hepatocellular carcinoma (liver cancer) is expected to kill more than 15,000 Americans in 2005. Surgery is the only known curative treatment for this type of cancer, but fewer than 20 percent of patients are eligible for surgery. Although some patients may benefit from local treatments other than surgery, most patients with inoperable liver cancer are treated with systemic chemotherapy.

Treatment with the drug doxorubicin has provided the best results so far for liver cancer patients with inoperable tumors. Unfortunately, fewer than 20 percent of patients respond to treatment with doxorubicin. In this clinical trial, researchers are adding a new drug called bortezomib to chemotherapy with doxorubicin to see if it can cause liver tumors to shrink or stop growing better than doxorubicin alone. Bortezomib, a proteasome inhibitor, blocks the activity of a number of proteins important for cell survival, tumor growth, and angiogenesis (the formation of new blood vessels to the tumor). In other types of cancer, bortezomib has been shown to delay tumor growth and enhance the cell-killing effects of chemotherapy.

"Results from our laboratory studies suggest that combining doxorubicin and bortezomib is more effective against liver cancer than either agent alone," said Dr. Berlin. "We hope that by adding bortezomib to the standard treatment for liver cancer, we can better control this difficult-to-treat disease."

Who Can Join This Trial?
Researchers seek to enroll 40 patients aged 18 and over with a confirmed diagnosis of hepatocellular carcinoma that is not amenable to curative surgery. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/ECOG-E6202.

Where Is This Trial Taking Place?
Study sites in the United States are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/ECOG-E6202.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-E6202 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is completely confidential.