Gemcitabine & Nab-Paclitaxel in Pancreatic Adenocarcinoma With Positive Peritoneal Cytology

This research study is a Phase Ib clinical trial. It will assess the frequency of cytological
conversion in patients with pancreatic adenocarcinoma and positive peritoneal cytology as a
sole metastatic site following gemcitabine nab-paclitaxel.

Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer
with positive peritoneal cytology as a sole metastatic site and meet all inclusion/exclusion
criteria.

Treatment consists of 4 week treatment cycles. Nab-paclitaxel and gemcitabine will be
administered on days 1,8, and 15.

Inclusion Criteria:

1. Male, or a non-pregnant and non-lactating female.

2. Age ≥ 18 years.

3. Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC).

4. Radiographic and pathologic staging (including staging laparoscopy with peritoneal
wash) consistent with pancreatic cancer, resectable, borderline resectable, or locally
advanced or unresectable as defined by NCCN guidelines
(http://www.nccn.org/professionals/physician_gls/f_guidelines.asp).

5. Laparoscopic confirmation that the PDAC is localized except for positive peritoneal
cytology. Biliary stents are permitted.

6. Elevated CA19-9.

7. Measurable disease as defined by RECIST 1.1.

8. ECOG performance status of ≤ 1 (see Appendix A).

9. Adequate bone marrow reserves as evidenced by:

- ANC ≥1,500 cells/μl; and

- Platelet count ≥100,000 cells/μl; and

- Hemoglobin ≥9 g/dL

10. Adequate hepatic function as evidenced by:

- Serum total bilirubin 1.5 ≤; and

- AST and ALT ≤2.5 x ULN; and

- Alkaline phosphatase ≤2.5 x ULN

11. Adequate renal function as evidenced by creatinine ≤1.5 x ULN.

12. Women 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 for 28 days prior to starting
gemcitabine/nab- paclitaxel (including dose interruptions) and for 3 months after
last dose of gemcitabine/nab-paclitaxel and

2. Have a negative pregnancy test result at screening and agree to ongoing pregnancy
testing at the Investigator's discretion during the course of the study. This
applies even if the subject practices true abstinence from heterosexual contact.

13. Male subjects must practice true abstinence or agree to use a condom during sexual
contact with a female of childbearing potential or a pregnant female while on
treatment (including during dose interruptions) with gemcitabine/nab-paclitaxel and
for 3 months following the last dose of gemcitabine/nab- paclitaxel, even if he has
undergone a successful vasectomy.

Exclusion Criteria:

1. Prior chemotherapy or radiation for pancreatic cancer.

2. CA19-9 non-expressing.

3. Previous (within the past 5 years) or concurrent, malignancy diagnosis, except
non-melanoma skin cancer and in situ carcinomas.

4. History of allergy or hypersensitivity to human, humanized or chimeric monoclonal
antibodies.

5. Any medical or surgical condition that may place the subject at increased risk while
on study.

6. Any condition potentially decreasing compliance to study procedures.

7. Participation in any other clinical protocol or investigational trials within 60 days
prior to Day 1, Cycle 1.

8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
systemic infection, symptomatic congestive heart failure, unstable angina pectoris,
clinically significant cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements.

9. Current abuse of alcohol or illicit drugs.

10. Any medical condition that, in the opinion of the Investigator, may pose a safety risk
to the subject, may confound the assessment of safety and efficacy, or may interfere
with study participation.

11. Have ≥ Grade 2 pre-existing peripheral neuropathy (per CTCAE).

12. Inability or unwillingness to sign the informed consent form.