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- Title
Phase I and Pharmacokinetic Evaluation of Intravenous Hyaluronic Acid in Combination with Doxorubicin or 5-Fluorouracil.
- Authors
Rosenthal, Mark A.; Gibbs, Peter; Brown, Tracey J.; Wong, Shirley; Uren, Shannon; Ellis, Andrew; Lingli Li; Heldin, Paraskevi; Fox, Richard M.
- 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/m2 HA in combination with escalating doses of DOX (30–60 mg/m2) or 5-FU (cumulative dose of 1,350–2,250 mg/m2 per cycle). The effect of pre-administration of 20 mg/m2 of folinic acid on HA/5-FU chemotherapy was also investigated. Patients were randomized to receive either HA/chemotherapy or chemotherapy alone in their first treatment cycle and vice versa for the second cycle. Patients received HA and chemotherapy in all subsequent cycles. Results:Treatment was well tolerated, tumour responses were observed and the co-administration of HA did not alter the pharmacokinetics of clinically relevant doses of 5-FU or DOX. Conclusion:High doses of intravenous high-molecular-weight HA can be safely co-administered with clinical doses of chemotherapy without significantly altering the toxicity or pharmacokinetics of the drugs or HA. Copyright © 2005 S. Karger AG, Basel
- Subjects
HYALURONIC acid; DRUG therapy; PHARMACOKINETICS; FLUOROURACIL; DOXORUBICIN
- Publication
Chemotherapy (0009-3157), 2005, Vol 51, Issue 2/3, p132
- ISSN
0009-3157
- Publication type
Article
- DOI
10.1159/000085621