Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer
Status:
Completed
Trial end date:
2021-06-14
Target enrollment:
Participant gender:
Summary
The objective of this study is to improve survival by the addition of anakinra to the
chemotherapy combination of nab-paclitaxel, gemcitabine, and cisplatin in patients with
resectable or potentially resectable pancreatic adenocarcinoma (PDAC). The primary endpoint
of the study is to determine whether the combination of abraxane, gemcitabine, cisplatin, and
anakinra will improve disease-free survival (DFS) and to determine the number of patients who
meet or surpass 11.5 months of DFS.
The secondary objectives of this study are to evaluate the effect of anakinra when combined
with the three-drug regimen of nab-paclitaxel, gemcitabine, and cisplatin on response rate
and overall survival after diagnosis and adverse events of patients with resectable or
potentially resectable PDAC. The investigators will use the benchmark of 24 months overall
survival (OS) to determine how many patients meet or exceed this goal. The investigators will
monitor, by survey, patients' health related quality of life while on treatment to determine
if the addition of anakinra improves this measure.
Phase:
Early Phase 1
Details
Lead Sponsor:
Baylor Research Institute
Treatments:
Albumin-Bound Paclitaxel Cisplatin Gemcitabine Interleukin 1 Receptor Antagonist Protein Paclitaxel