Phase I and pharmacokinetic evaluation of intravenous hyaluronic acid in combination with doxorubicin or 5-fluorouracil

Abstract

Background: Pre-clinically, hyaluronan (HA) has been demonstrated to systemically target chemotherapeutic drugs to tumours while ameliorating treatment toxicities. This study is a preliminary clinical investigation to determine if HA could be safely used in combination with 5-fluorouracil (5-FU) and doxorubicin (DOX). Methods: Thirty patients with metastatic cancer were intravenously administered 500 mg/m 2 HA in combination with escalating doses of DOX (30-60 mg/m 2) or 5-FU (cumulative dose of 1,350-2,250 mg/m 2 per cycle). The effect of pre-administration of 20 mg/m 2 of folinic acid on HA/5-FU chemotherapy was also investigated. Patients were randomized to receive either HA/chemotherapy ..