A Phase I Study of Gemcitabine and Docetaxel for Advanced Stage Solid Tumors

Abstract

Background: We conducted a phase I study to determine the maximum tolerated dose of docetaxel in combination with gemcitabine for patients with refractory solid tumors. Methods: From January 1998 to November 1999, we treated 28 patients on a phase I protocol with gemcitabine given at a constant dose of 800 mg/m² IV over 30 minutes on days 1, 8, and 15. Docetaxel was administered by a phase I schedule over 1 hour on day 1 of a 28-day cycle with a starting dose of 50 mg/m² and increased by increments of 10 mg/m² based on dose-limiting toxicity (DLT) that occurred in the first cycle. Results: Neutropenia and thrombocytopenia were the dose-limiting toxicities. The maximum tolerated dose was 60 mg/m². The most significant nonhematologic toxicities included fatigue, nausea, vomiting, mucositis, and hypersensitivity reactions. There was one partial response at 15 months in a patient with gastric cancer and six patients with stable disease for 4.0 to 15.0 months. Conclusions: The maximum tolerated dose of docetaxel with gemcitabine is 60 mg/m². A phase II study in selected primary sites is planned.

• Gemcitabine
• Docetaxel
• Solid tumors