Study of Gemcitabine and Abraxane for Pancreas Cancer

This is an open label Phase II study to evaluate the clinical activity of the combination of
gemcitabine and nab-paclitaxel (abraxane) as second line treatment in patients with
metastatic pancreatic cancer who have received non-gemcitabine-based chemotherapy in the
first line setting. All patients will receive both drugs on Days 1, 8, 15 every 28 days. The
hypothesis is that this combination will have a 4-month progression free survival of 70% or
higher.

Inclusion Criteria:

- Histologically confirmed metastatic adenocarcinoma of the pancreas

- Progression on first line non-gemcitabine based therapy for metastatic or relapsed
disease

- Radiographically measurable or evaluable disease

- Age >/= 18 years

- ECOG performance status 0-2

- Adequate hepatic, bone marrow and renal function

Exclusion Criteria:

- Prior gemcitabine-based chemotherapy in the first line setting

- No active severe infection, or known chronic infection with HIV or hepatitis B virus

- No cardiovascular disease problems including unstable angina, therapy for
life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or
congestive heart failure within the last 6 months

- No women who are pregnant or breastfeeding, and no women of childbearing potential
without using dual forms of contraception

- Patients with known CNS metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemcitabine or nab-paclitaxel

- Anticipated patient survival under 2 months