Name of the Trial
Phase II Study of Isolated Hepatic Perfusion with Melphalan followed by Leucovorin Calcium, Oxaliplatin, and Fluorouracil in Patients with Previously Untreated Unresectable Liver Metastases Secondary to Colorectal Cancer (NCI-05-C-0025). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-05-C-0025.

Principal Investigator
Dr. H. Richard Alexander, CCR, NCI

Why Is This Trial Important?
Colorectal cancer is expected to cause more than 56,000 deaths in the United States in 2005. Mortality is high because colorectal cancer is usually diagnosed at an advanced stage when the cancer has metastasized (spread) to other parts of the body, most frequently to the liver. Almost 70 percent of deaths attributed to colorectal cancer occur in patients with liver metastases.

The only curative treatment available for liver metastases resulting from colorectal cancer is surgical removal (resection). However, most patients are not eligible for tumor resection because of the size, number, or location of their metastases.

In this study, researchers are combining local treatment of liver metastases through isolated hepatic perfusion (IHP) and standard systemic chemotherapy to determine whether this combined approach may prolong patients' lives. In IHP, the flow of blood to and from the liver is temporarily isolated from the rest of the body so that high doses of anticancer drugs, such as melphalan, can be delivered to the liver while sparing other tissues. Response rates to IHP in other clinical trials have been promising, with significant regression of visible metastases occurring in many patients.

However, patients with liver metastases are at high risk of having developed undetectable (occult) metastases elsewhere in the body. The researchers hope that following IHP with systemic chemotherapy may not only enhance the effects of IHP on detectable liver metastases but also eradicate occult metastatic tumors.

Who Can Join This Trial?
Researchers will recruit 30 colorectal cancer patients over 18 years of age who have been diagnosed with liver metastases. See the complete list of eligibility criteria at http://www.cancer.gov/clinicaltrials/NCI-05-C-0025.

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.