Phase I study of Doxil and vinorelbine in patients with advanced malignancies.

Introduction: This study was designed to define the maximum tolerated dose of pegylated liposomal doxorubicin (Doxil) and multiday vinorelbine (VNB), without and with prophylactic filgrastim, and to identify antineoplastic effect.

Patients And Methods: Patients with resistant cancers were treated with Doxil 50 mg/m2 every four weeks, and with VNB 15 mg/m2 on the same day. The VNB dose escalations were accomplished in subsequent patient cohorts by adding VNB doses on consecutive days.