Phase I Trial and Pharmacokinetic (PK) and Pharmacodynamics (PD) Study of Topotecan Using a Five-Day Course in Children with Refractory Solid Tumors

Abstract

In heavily pretreated children, the MTD for topotecan given by intermittent 30-min infusion for 5 days is 1.4 mg/m2 without GCSF and 2.0 mg/m2/day with GCSF. The dose-limiting toxicity is hematopoietic. Data from this study provide the basis for further studies of topotecan in children with cancer.