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Name of the Trial

Phase II Study of Isolated Hepatic Perfusion With Melphalan in Patients With Unresectable Colorectal Cancer Metastatic to the Liver and Refractory to First-Line Systemic Chemotherapy (NCI-04-C-0229). See the protocol summary ³.

Principal Investigator

Dr. H. Richard Alexander Principal Investigator

Dr. H. Richard Alexander, NCI Center for Cancer Research.

Why This Trial Is Important

More than 145,000 people in the United States will be diagnosed with colorectal cancer this year, making it the third most common cancer in the United States. Approximately half of diagnosed patients will suffer from advanced disease that has spread (metastasized) to other parts of the body, most commonly to the liver. Nearly 70 percent of the deaths attributed to colorectal cancer occur in patients who have liver metastases.

Many metastatic colorectal tumors in the liver cannot be removed surgically and often respond to systemic combination chemotherapy for only a short time.

In this phase II study, researchers are using a surgical procedure known as isolated hepatic perfusion (IHP) to deliver melphalan, an anticancer drug, directly to the liver while avoiding unnecessary systemic toxicity. Melphalan causes significant regression of metastatic tumors in the liver when given at very high doses, an effect that can help extend the lives of some patients for many months. Isolated perfusion was developed to confine drugs such as melphalan to a target organ or limb, thus sparing normal tissues from toxic effects.

"We can think of IHP as a physical method of targeting relatively nonspecific anticancer drugs to the sites of metastatic disease," said Dr. Alexander. "Because it is a one-time therapy with notable antitumor activity, we hope it will substantially improve the quality of life of patients with refractory advanced colorectal cancer."

Contact Information

This clinical trial is no longer accepting patients. To locate other clinical trials for colorectal cancer, search the NCI's database of clinical trials ¹ or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

Glossary Terms

A procedure in which a catheter is placed into the artery that provides blood to the liver. A second catheter is placed into the vein that takes blood away from the liver. This temporarily separates the liver's blood supply from blood circulating throughout the rest of the body and allows high doses of anticancer drugs to be directed to the liver only.

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Treatment with anticancer drugs that travel through the blood to cells all over the body.