Phase I Study of Weekly Vinorelbine in Combination with Weekly Paclitaxel in Adult Patients with Advanced Refractory Cancer

Abstract

Vinorelbine and paclitaxel are highly active antineoplastic agents. Preclinical data indicate a potential for antitumor synergy for a number of common tumor types when they are combined. We investigated a novel weekly schedule of both agents. Eighteen patients with advanced cancer were entered onto this phase I trial. Vinorelbine and paclitaxel were given weekly in combination for 6 consecutive weeks, followed by a 2-week break. Sequential cohorts of patients were treated at two dose levels: Vinorelbine 22.5 mg/m² followed by paclitaxel 40 mg/m² and Vinorelbine 22.5 mg/m² followed by paclitaxel 60 mg/m². Ten patients completed at least one 8-week course of therapy. Neutropenic myelosuppression was dose limiting at level II. Neurotoxicity was not dose limiting. Objective responses were seen in patients with esophageal, lung, and breast cancer and suggest that this is an active regimen worthy of further investigation in selected diseases. Phase II trials of this regimen are in progress.