Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria

• •1. Age ≥ 18 years of age; male or female
• •2. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
• •3. Capable of providing informed consent and complying with trial procedures.
• •4. Karnofsky Performance Status (KPS) of ≥ 70%.
• •5. Life expectancy ≥ 12 weeks.
• •6. Measurable tumor lesions according to RECIST 1.1 criteria.
• •7. \< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
• •8. Patient has acceptable coagulation status as indicated by an international normalized ratio (INR) ≤1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
• •9. Patients must have normal organ and marrow function as defined below:
• •* Absolute neutrophil count ≥1,500/mm3
• •* Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days prior to laboratory sample
• •* Hemoglobin \> 9.0g/dL
• •* Hematocrit level \> 27%
• •* Total bilirubin within 1.25 times institutional upper limit of normal (ULN)
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 10 × institutional ULN
• •* Serum creatinine \<1.5 mg/dl
• •10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or (2) has not been naturally postmenopausal for at least 24 consecutive months \[i.e., has had menses at any time during the preceding 24 consecutive months\]) must:
• •1. Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and
• •2. Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence\* from heterosexual contact.
• •11. Male subjects must practice true abstinence\* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation from study treatment, even if he has undergone a successful vasectomy.