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.
This is a single-arm, open-label pilot study. Patients will receive Nab-paclitaxel, gemcitabine, cisplatin and anakinra.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Disease Free Survival (DFS)
determine the number of patients who meet or surpass 11.5 months of disease free survival
Time frame: 2 Years
Overall Survival (OS)
The use of a benchmark of 24 months overall survival will be used to determine how many patients meet or exceed this goal.
Time frame: 2 years
Quality of Life
The use of surveys will capture the patients' health-related quality life while on treatment to determine if the addition of anakinra improves this measure.
Time frame: 2 years
Toxicities and Adverse Events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Toxicities and adverse events will be recorded from the of informed consent to 30 days following the last study treatment.
Time frame: 2 years
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