Pilot Study of Intra-Arterial Floxuridine, Mitomycin and Doxorubicin in Combination with Degradable Starch Microspheres to Treat Primary and Metastatic Tumors of the Liver

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Abstract
Concurrent administration of degradable starch microspheres and cytostatic agents into the hepatic artery results in decreased systemic exposure and increased hepatic exposure to drug compared to intra-arterial administration of drug alone. Degradable starch microspheres 210 mg/m2 mixed with floxuridine 500 mg/m2, doxorubicin 40 gm/m2, and mitomycin 10 mg/m2 were administered through hepatic artery catheters to eleven patients with primary or metastatic cancer of the liver. Toxicity was acceptable and consisted of severe myelosuppression (5%), duodenal/gastric ulceration (9%), mild to moderate nausea and vomiting (17%) and alopecia (86%). There were no responses among the eleven patients; 7 of 7 pateints with colo-rectal carcinoma had stable desease while on study. Minimal activity was observed in 7 patients with colo-rectal carcinoma. The use of degradable starch microspheres offers a new approach to the regional treatment of cancer and warrants further study.