Stage IV Pancreatic Cancer Clinical Trial
Official title:
A Phase 1b/2 Pilot Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine (Nabplagem) in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
The primary objective of this study is to determine the efficacy of nab-paclitaxel plus cisplatin plus gemcitabine for patients with metastatic pancreatic ductal adenocarcinoma (PDA).
This is a phase 1b/2 open-label pilot study evaluating the preliminary efficacy and safety of
nab-paclitaxel, cisplatin, and gemcitabine in patients with metastatic pancreatic ductal
adenocarcinoma.
An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles
may be administered until the patient is withdrawn from therapy.
Overall response rates as well as individual categories of response (complete response-CR,
partial response-PR, stable disease-SD and progressive disease-PD) will be determined using
RECIST 1.1. Time-to-event endpoints, including progression free survival (PFS) and OS
(overall survival) will be assessed using the Kaplan-Meier method. Evaluation of stable
disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using
the NCI CTCAE (v4.0, May 2009).
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