Name of the Trial
Phase III Randomized Study of Gemcitabine with Versus without Bevacizumab in Patients with Locally Advanced or Metastatic Adenocarcinoma of the Pancreas (CALGB-80303). See the protocol summary at http://cancer.gov/clinicaltrials/CALGB-80303.

Principal Investigator
Dr. Hedy Lee Kindler, Cancer and Leukemia Group B

Why Is This Trial Important?
Pancreatic cancer is the fourth leading cause of cancer death in the United States. Patients with pancreatic cancer are usually diagnosed with advanced disease because this type of cancer often spreads before symptoms develop. Current treatments may extend survival slightly or relieve symptoms in some patients, but they rarely produce a cure.

In this study, researchers are adding a biological agent called bevacizumab (Avastin) to standard chemotherapy with the drug gemcitabine to see if the combination can help improve the survival of pancreatic cancer patients whose disease has spread to nearby lymph nodes (locally advanced) or to other sites in the body (metastatic). Bevacizumab is a monoclonal antibody that blocks the action of a protein called vascular endothelial growth factor (VEGF). VEGF stimulates the growth of new blood vessels (angiogenesis), which tumors need to survive, and it may also act as a growth factor for pancreatic cancer cells, stimulating them to multiply. Researchers hope they can cause pancreatic tumors to shrink or die by blocking VEGF activity.

"In a phase II study we conducted with this combination, we observed a time to progression and survival that was far better than we expected," said Dr. Kindler. "This randomized trial seeks to confirm our observations, and we hope that the laboratory studies we are also performing will teach us a great deal about the biology of pancreatic cancer."

Who Can Join This Trial?
Researchers seek to enroll 590 patients aged 18 and over with locally advanced or metastatic pancreatic cancer that cannot be removed surgically. See the list of eligibility criteria at http://www.cancer.gov/clinicaltrials/CALGB-80303.

Where Is This Trial Taking Place?
Multiple study sites in the United States are recruiting patients for this trial. See the list of study sites at http://www.cancer.gov/clinicaltrials/CALGB-80303.

Contact Information
See the list of study contacts at http://www.cancer.gov/clinicaltrials/CALGB-80303 or call NCI's Cancer Infor-mation Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.