TIGeR-PaC: Targeted Intra-arterial Gemcitabine vs. Continuation of IV Gemcitabine plus Nab-Paclitaxel following Induction with sequential IV Gemcitabine plus Nab-Paclitaxel and Radiotherapy for Unresectable Locally Advanced Pancreatic Cancer
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Klute, Kelsey
Eligibility: https://clinicaltrials.gov/study/NCT03257033?term=NCT03257033&rank=1
Summary
Primary Objective
To compare the Overall Survival (OS), from time of randomization until death, between subjects receiving IA delivery of gemcitabine using the RenovoCath® device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks, in those subjects with stable disease following induction therapy with IV gemcitabine and nab-paclitaxel as well as radiation treatment for unresectable locally advanced pancreatic adenocarcinoma.
Secondary Objectives
To compare in subjects with locally advanced, unresectable pancreatic cancer treated with IA delivery of gemcitabine using the RenovoCath® device for 16 weeks vs. continuation of IV gemcitabine and nab-paclitaxel for 16 weeks:
1. Primary Endpoint for treatment received and unresected analysis populations
2. Progression free survival (PFS) assessed according to RECIST 1.1 for all analysis populations
3. Objective response rate (ORR) and duration of response (DoR)
4. Health Related Quality of Life (QoL) assessed with the EORTC QLQ-C30 questionnaire
5. Degree of peripheral neuropathy assessed with the FACT/GOG-NTX-4 questionnaire
6. Frequency of neutropenia requiring the use of filgrastim or other medications for white blood cell stimulation
7. Tolerability and safety of the combination