Weekly administration of gemcitabine plus docetaxel in patients with advanced breast cancer: a phase 1 study.

2002

<i>Objective:</i> This study was designed to determine the maximum tolerable dose (MTD) of gemcitabine plus docetaxel, both given on a weekly schedule, in patients with pretreated metastatic breast cancer (MBC). <i>Methods:</i> Heavily pretreated patients with MBC, aged 18–75 years with World Health Organization performance status of 0–2 were enrolled. Three escalating weekly doses of docetaxel (30, 35 and 40 mg/m<sup>2</sup>) followed by a weekly fixed dose of gemcitabine, 800 mg/m<sup>2</sup>, were administered on days 1, 8 and 15 of a 28-day cycle. Dose-limiting toxicity (DLT) included grade >3 hematologic toxicity and grade >2 stomat…