Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia

Inclusion Criteria:

* Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy that has progressed through or intolerant to gemcitabine based chemotherapy
* Cachexia defined as greater than 5% unexplained weight loss within any 6 month period prior to screening visit OR as documented by the medical physician based on standard diagnosis of cachexia
* Age ≥ 18 years
* ECOG performance status 0-2 or Karnofsky PS \>60%
* Patients must have normal organ and marrow function
* Ability to understand and the willingness to sign a written informed consent
* Negative pregnancy test for WOCBP
* WOCBP and men must agree to use of adequate contraception

Exclusion Criteria:

* Patients who are currently receiving any other investigational agents
* Patients who have received more than one chemotherapeutic regimen in metastatic setting
* Patients with CNS metastases
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment
* Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix or Onivyde
* Women who are pregnant or breastfeeding
* Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* Patients with known Dihydropyrimidine dehydrogenase deficiency (DPD deficiency)
* Patients known to be UGT1A1\*28 allele homozygous
* Patients who have had a live vaccine within 3 months of enrollment