A Phase II Trial of Nab-Paclitaxel plus Cisplatin plus Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

The purpose of this study is to find out if the study drugs nab-paclitaxel, cisplatin, and gemcitabine given together are safe and effective. The combination of nab-paclitaxel plus gemcitabine has been studied in treating patients with pancreatic cancer, and as of September 2013 is approved for the treatment of advanced pancreatic cancer. In this study, cisplatin will be added to nab-paclitaxel plus gemcitabine and tested in people who have not yet had any cancer therapy for the diagnosis of advanced pancreatic cancer, with the goal of improving response. Another name for nab-paclitaxel is Abraxane^®. Nab-paclitaxel contains the same medication as the prescription chemotherapy drug Abraxane^®. Nab-paclitaxel is approved by the FDA for the treatment of advanced breast cancer, and in September 2013 nab-paclitaxel, combined with gemcitabine, was approved by the FDA for the treatment of advanced pancreatic cancer. Cisplatin is approved by the FDA for the treatment of advanced bladder cancer, advanced ovarian cancer, and advanced testicular cancer and other childhood cancers. However, cisplatin is not approved by the FDA for the treatment of advanced pancreatic cancer. Gemcitabine was approved by the FDA in 1996 for the treatment of pancreatic cancer. It is also an approved treatment for ovarian cancer, lung cancer, and breast cancer. The Food and Drug Administration (FDA) has determined that this study meets the requirements for Investigational New Drug (IND) Exemption.