A phase I trial of hepatic artery fluorodeoxyuridine combined with systemic 5-fluorouracil for the treatment of metastases from colorectal cancer

In order to determine whether systemic FUra could be safely administered with hepatic artery FdUrd we conducted a phase I study of FdUrd 0.3 mg kg^-1 day^-1 for 14 days combined with increasing doses of systemic FUra for 5 days beginning on day 15 of each 28-day cycle. Eleven patients with metastatic colorectal cancer in which the liver was the only or the predominant site of disease are evaluable for response and toxicity. Seven patients (64%) achieved a partial response. The median time to progression was 11 months. Toxicity was comparable to that expected for either treatment alone, with the exception of an increased incidence of dermatological toxicity. In summary, systemic FUra could be safely combined with hepatic artery FdUrd; however, mild dose reductions were necessary to prevent excess toxicity.