Conditions: Stage IV Pancreatic Cancer
Keywords: pancreatic cancer pancreatic adenocarcinoma Stage IV pancreatic cancer pancreas pancreatic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
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).

Detailed description:
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 Multiple cycles may be administered until the patient is withdrawn from therapy.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).

Arms:
arm 1: This is a phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of nab-paclitaxel 125mb/m2, cisplatin 25mg/m2, and gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression.

Interventions: intervention 1: nab-paclitaxel intervention 2: Cisplatin intervention 3: gemcitabine
Intervention descriptions: intervention 1: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle intervention 2: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle intervention 3: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle

Protocol document: