Phase I of fixed-dose-rate gemcitabine in combination with bortezomib in patients with advanced solid tumors

TL;DRAbstract

2563 Background: Administration of gemcitabine via fixed-dose rate (FDR) infusion at 10 mg/m2/min has been shown to increase accumulation of the active phosphorylated metabolite of the drug. Additionally, phase II trials comparing FDR versus standard 30-minute bolus infusion of gemcitabine demonstrate superior median survival with the former in the setting of advanced pancreatic carcinoma. Bortezomib is a proteasome inhibitor with efficacy in refractory multiple myeloma, and our preclinical data suggests synergism of this drug in combination with FDR gemcitabine. This phase I trial was set out to determine the safety, toxicity, and MTD of FDR gemcitabine with bortezomib in advanced solid tumors refractory to standard therapy. Methods: 29 patients (16 male, 13 female) with a median age of 63 (range 36–84) have been enrolled, 25/29 patients (86%) with ECOG performance status of 0–2. A wide array of primary sites of malignancy has been represented in enrollment (11 lung, 4 breast, 3 gastr

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