A phase I study of weekly gemcitabine and docetaxel in patients with advanced cancer: A Hoosier Oncology Group study

Purpose: To determine the maximum tolerated dose (MTD) of weekly gemcitabine plus docetaxel, a dose escalation trial of both drugs was developed with each administered weekly for 3 weeks out of 4. Patients and Methods: Dose levels for gemcitabine (mg/m(2)) and docetaxel (mg/m2) were as follows: level 1: 600/25; level 2: 600/35; level 3: 750/35; and level 4: 900/35. Sixteen patients with adequate renal, hepatic, and hematologic function and an Eastern Cooperative Oncology Group performance status of 0-2 were treated. Primary sites included pancreas (12) and others (4). Results: Three patients were treated at each dose level from level 1 through level 4. The dose-limiting toxicity (DLT) was neutropenia, the maximum tolerated dose being 750 mg/m2 of gemcitabine and 35 mg/m2 of docetaxel. No grade 4 nonhematologic toxicity was seen. Three patients had grade 4 neutropenia. Of the 12 patients with pancreatic cancer, 1 had a partial remission and 7 had stable disease with a median duration of 8 weeks. Conclusions: Gemcitabine and docetaxel can be safely administered weekly at a dose of 750 and 35 mg/m2, respectively. The DLT was neutropenia. Disease stabilization suggests that this may be an active regimen in patients with metastatic pancreatic cancer. Copyright (C) 2002 S. Karger AG, Basel.