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A Dose Escalation Trial of Biweekly Docetaxel and Gemcitabine with Filgrastim or Pegfilgrastim for the Treatment of Patients with Advanced Solid Tumors

Background/Aims: A single-institution phase I trial to determine the feasibility of using filgrastim or pegfilgrastim to increase the dose intensity of biweekly docetaxel and gemcitabine. Methods: Patients with metastatic solid tumors received gemcitabine 3,000 mg/m2 and increasing doses of docetaxel (55 mg/m2 in 10 mg/m2 increments) every 14 days with filgrastim or pegfilgrastim. Results: 35 patients enrolled, median 2 prior therapies, 158 cycles of therapy. There was 1 dose-limiting toxicity (DLT) (sepsis) at docetaxel 55 mg/m2, 1 DLT (sepsis/diarrhea) at docetaxel 65 mg/m2, and no DLT at docetaxel 75 mg/m2. At docetaxel 85 mg/m2, 2/4 patients had DLT (fatigue/dyspnea, diarrhea). The maximum tolerated dose (MTD) of docetaxel was 75 mg/m2. 1/12 patients treated at MTD experienced DLT (sepsis/dyspnea). The initial 25 patients received filgrastim (average 7 doses/cycle), the last 10 received pegfilgrastim. Conclusions: The MTD for docetaxel was 75 mg/m2 with gemcitabine 3,000 mg/m2 given every 14 days with filgrastim or pegfilgrastim. This regimen was well tolerated with signs of clinical activity. We found no significant differences in toxicities or effectiveness between daily filgrastim and pegfilgrastim given 13 days before the next chemotherapy. The use of granulocyte growth factors allowed increased dose intensity of docetaxel and gemcitabine. This regimen warrants further study in chemotherapy-naïve patients and patients with earlier stages.