Phase I/II trial to evaluate the efficacy and safety of nanoparticle albumin-bound paclitaxel in combination with gemcitabine in patients with pancreatic cancer and an ECOG performance status of 2
Journal of Clinical Oncology Jan 22, 2019
Macarulla T, et al. - Researchers evaluate the efficacy and tolerability of different gemcitabine plus nanoparticle albumin-bound (NAB) paclitaxel (GA) dosing regimens in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) and poor Karnofsky performance status (70% or greater). In the phase I part of this study, they randomly assigned patients to one of the following four parallel GA treatment arms (six patients per arm): a biweekly schedule of NAB-paclitaxel (150 mg/m2 [arm A] or 125 mg/m2 [arm C]) plus gemcitabine 1,000 mg/m2 or a standard schedule of 3 weeks on and 1 week off of NAB-paclitaxel (100 mg/m2 [arm B] or 125 mg/m2 [arm D]) plus gemcitabine 1,000 mg/m2. Administration of NAB-paclitaxel at either 100 and 125 mg/m2 in combination with gemcitabine on days 1, 8, and 15 every 28 days in these patients was well tolerated and resulted in acceptable safety and effectiveness.
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