Gemcitabine Plus nab-Paclitaxel Is an Active Regimen in Patients With Advanced Pancreatic Cancer: A Phase I/II Trial
Purpose
The trial objectives were to identify the maximum-tolerated dose (MTD) of first-line gemcitabine plus nab-paclitaxel in metastatic pancreatic adenocarcinoma and to provide efficacy and safety data. Additional objectives were to evaluate positron emission tomography (PET) scan response, secreted protein acidic and rich in cysteine (SPARC), and CA19-9 levels in relation to efficacy. Subsequent preclinical studies investigated the changes involving the pancreatic stroma and drug uptake.
Von Hoff D.D., Ramanathan R.K., Borad M.J., Laheru D.A., Smith L.S., Wood T.E., Korn R.L., Desai N., Trieu V., Iglesias J.L., Zhang H., Soon-Shiong P., Shi T., Rajeshkumar N.V., Maitra A., Hidalgo M. “Gemcitabine Plus nab-Paclitaxel Is an Active Regimen in Patients With Advanced Pancreatic Cancer: A Phase I/II Trial.” J Clin Oncol., 29(34): 4548-54, (2011).