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 at http://cancer.gov/clinicaltrials/NCI-04-C-0229.

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

Why Is This Trial 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.”

Who Can Join This Trial?
The researchers will recruit 30 patients over 18 years of age diagnosed with colorectal cancer metastases of the liver. See the complete list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-04-C-0229.

Where Is This Trial Taking Place?
The study is taking place at the NIH Clinical Center in Bethesda, Md.

Contact Information
For more information, call the NCI Clinical Studies Support Center at 1-888-NCI-1937. The toll-free call is confidential.

An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.