Pancreatic Cancer

The purpose of this study is to find out if the study drug ABI-007 given together with another drug, Gemcitabine (a drug approved for the treatment of pancreatic cancer), is as safe and effective as Gemcitabine alone in patients with metastatic pancreas cancer.

ABI-007 is also known as Abraxane® and is approved by the FDA for the treatment of certain types of breast cancer. Participants in this study will either get ABI-007 plus Gemcitabine treatment, or Gemcitabine treatment alone. Participants will be assigned randomly to one of two treatment groups.

Participants will receive study treatment at the Seattle Cancer Care Alliance (SCCA). If hospitalization is needed while in Seattle, participants will be admitted to the University of Washington Medical Center (UWMC).

There are typically 3 treatment visits per month during the course of the study. Patients are monitored weekly for the development of any side effects.

• 18 years of age or older

• Diagnosed with metastatic pancreas cancer

• One or more metastatic tumors

• No previous therapy for treatment of metastatic disease

Other eligibility criteria may apply.

• Previously treated for metastatic pancreas cancer

• Pregnant or breastfeeding

• Known brain metastases unless previously treated and well-controlled for at least 3 months

• Use of Coumadin

• Active, uncontrolled infection requiring systemic therapy

• Known historical or active infection with HIV, hepatitis B or C

• History of connective tissue disorders (e.g., lupus, scleroderma, arteritis nodosa)

• History of chronic leukemias (e.g., chronic lymphocytic leukemia)

• Patients with high cardiovascular risk, including, but not limited to, recent coronary stenting or myocardial infarction in the past year

• History of Peripheral Artery Disease (e.g,. claudication, Buerger's disease)

Other exclusion criteria may apply.