Northwestern researchers launch Avastin trial for pancreatic tumors

February 21, 2006

A Phase II clinical trial is under way at Northwestern Memorial Hospital in conjunction with the Northwestern University Feinberg School of Medicine to determine if bevacizumab (also referred to as Avastin®, an anti-angiogenesis drug that is designed to inhibit the growth of blood vessels in tumors) in combination with abdominal radiation therapy and chemotherapy can reduce localized pancreatic tumors that have not metastasized or spread to other systems or organs in the body. Northwestern Memorial is the sole clinical site where the research trial is being conducted.

Mark Talamonti, MD, chief of the Division of Surgical Oncology at Northwestern Memorial Hospital, associate professor of surgery at Northwestern University Feinberg School of Medicine and co-investigator on the study recently reported on a complementary trial, which looked at the effects of combining only chemotherapy and radiation on localized tumors. The results appeared in the February 2006 issue of the Annals of Surgical Oncology.

"Our findings from the previous study suggest that the combination of chemotherapy and radiation is a safe and effective treatment method to reduce the local extent of pancreatic tumors," said Dr. Talamonti.

"The current study, which will be conducted over two years, will help us evaluate whether adding Avastin may also provide an effective combination to reduce the tumor and increase survival rates," added William Small, Jr., MD, radiation oncologist, Northwestern Memorial Hospital, associate professor, Radiation Oncology, Northwestern University Feinberg School of Medicine and principal investigator for the trial.

Avastin is designed to inhibit Vascular Endothelial Growth Factor (VEGF), a protein that plays an important role in tumor angiogenesis or blood vessel formation, and maintenance of existing tumor vessels. By inhibiting VEGF, Avastin is thought to interfere with the blood supply to tumors, a process that is critical to tumor growth and metastasis.

According to the American Cancer Society, pancreatic cancer is the fourth leading cause of cancer death among adults in America. Approximately 1 out of 4 patients with pancreatic cancer will live at least one year after the cancer is found. Only about 1 in 25 will survive for five years or more. Further, it is estimated that in 2005, nearly 32,000 will be diagnosed and around 31,000 will die from it.
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Northwestern is seeking to enroll 40 participants with localized pancreatic cancer in stages 1, 2, or 3, and who have not had surgery to resect the tumor. Those interested in participating in the study should call Northwestern Memorial Hospital at 312-926-8400.

Avastin was developed by Genentech, Inc, and is approved in combination with intravenous 5-FU-based chemotherapy as a first-line treatment for metastatic colorectal cancer. Genentech is providing support for this trial and has approved this release.

About Northwestern Memorial Hospital
Northwestern Memorial Hospital is one of the country's premier academic medical centers and is the primary teaching hospital of Northwestern University Feinberg School of Medicine. Northwestern Memorial and its Prentice Women's Hospital and Stone Institute of Psychiatry have 744 beds and more than 1,200 affiliated physicians and 5,000 employees. Providing state-of-the-art care, Northwestern Memorial is recognized for its outstanding clinical and surgical advancements in such areas as cardiothoracic and vascular care, gastroenterology, neurology and neurosurgery, oncology, organ and bone marrow transplantation, and women's health.

Northwestern Memorial received the prestigious 2005 National Quality Health Care Award and is listed in eight specialties in this year's US News & World Report's issue of "America's Best Hospitals." The hospital is also cited as one of the "100 Best Companies for Working Mothers" by Working Mother magazine for the past 6 years and has been chosen by Chicagoans for a decade as their "most preferred hospital" in National Research Corporation's annual survey.

Avastin Safety Profile
Avastin has a well-established safety profile. In Genentech-sponsored studies, the most serious adverse events associated with Avastin were gastrointestinal perforation, wound healing complications, hemorrhage, arterial thromboembolic events, hypertensive crisis, nephrotic syndrome and congestive heart failure. The most common Grade 3-4 adverse events (occurring in greater than two percent of patients in the Avastin arm, compared to the control group) were asthenia, pain, hypertension, diarrhea and leukopenia. The most common adverse events (occurring in greater than two percent of patients in the Avastin arm, compared to the control group) of any severity were asthenia, pain, abdominal pain, headache, hypertension, diarrhea, nausea, vomiting, anorexia, stomatitis, constipation, upper respiratory infection, epistaxis, dyspnea, exfoliative dermatitis and proteinuria.

Northwestern Memorial HealthCare

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