Phase I study of weekly vinorelbine in combination with weekly paclitaxel in adult patients with advanced refractory cancer

Vinorelbine and paclitaxel are highly active antineoplastic agents. Preclin ical data indicate a potential for antitumor synergy for a number of common tumor types when they are combined. We investigated a novel weekly schedul e of both agents. Eighteen patients with advanced cancer were entered onto this phase I trial. Vinorelbine and paclitaxel were given weekly in combina tion for 6 consecutive weeks, followed by a 2-week break. Sequential cohort s of patients were treated at two dose levels: vinorelbine 22.5 mg/m(2) fol lowed by paclitaxel 40 mg/m(2) and vinorelbine 22.5 mg/m(2) followed by pac litaxel 60 mg/m(2). Ten patients completed at least one 8-week course of th erapy. Neutropenic myelosuppression was dose limiting at level II. Neurotox icity was not dose limiting. Objective responses were seen in patients with esophageal, lung, and breast cancer and suggest that this is an active reg imen worthy of further investigation in selected diseases. Phase II trials of this regimen are in progress.