Study of Gemcitabine and Abraxane for Pancreas Cancer

A Phase II Study of Gemcitabine and Nanoparticle-Bound Paclitaxel as Second Line Therapy in Patients With Metastatic Pancreatic Cancer

A Phase II trial of gemcitabine plus nab-paclitaxel in the second line setting

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