Gemcitabine, Nab-Paclitaxel, Cisplatin and Anakinra Treatment on Patients With Pancreatic Cancer

This is a single-arm, open-label pilot study. Patients will receive Nab-paclitaxel, gemcitabine, cisplatin and anakinra.

Inclusion criteria

A patient will be eligible for inclusion in this study if he or she meets all of the following criteria:

• Male or female ≥ 18 years of age.
• Suspected PDAC prior to diagnosis or histological diagnosis of adenocarcinoma of the pancreas confirmed by pathology. Mixed subtypes of adenocarcinoma are acceptable as long as majority of cells are ductal adenocarcinoma. Subjects with suspected PDAC are those without a biopsy and a pancreas mass which appears to be metastatic disease. These subjects will be enrolled prior to biopsy and then excluded if a diagnosis of pancreas cancer is not confirmed by histology.
• American Joint Committee on Cancer (AJCC) Stage I-III Pancreatic carcinoma.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
• Serum albumin ≥2.0 gm/dL.
• Expected survival ≥6 months.
• Adequate hematologic function as defined by:

• Absolute neutrophil count (ANC) >1500/mm3
• Platelets ≥70,000/mm3
• Hemoglobin >9 g/dL (in the absence of red blood transfusion).
• Adequate liver function, as defined by:

• Serum total bilirubin ≤2 x ULN mg/dL, prior to initiation of treatment.
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN).
• Adequate renal function, as defined by serum creatinine ≤ 1.5 x ULN, or creatinine clearance ≥50 mL/min
• All females of child bearing potential must agree to use contraception to avoid pregnancy throughout the study and for one month after the last dose.
• Patients must be accessible for treatment and follow-up.
• Patients must have the ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate. Patients may not be consented by a medical power of attorney.

Exclusion criteria

A patient will be ineligible for inclusion in this study if he or she meets any of the following criteria:

• < 18 years of age.
• History of organ transplant.
• Other malignancy within five years, unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information.
• Current, active immunosuppressive therapy such as cyclosporine, tacrolimus
• Significant or uncontrolled congestive heart failure (CHF), myocardial infarction or significant ventricular arrhythmias within the last 6 months.
• Active infection or antibiotics within 48 hours prior to study enrollment, including unexplained fever (temp > 38°C).
• Other severe and/or uncontrolled medical conditions or other conditions that in the opinion of the investigator could affect the participation of the patient on the study.
• Study consent form not signed.
• Pregnant or nursing women.
• Known HIV positive status.