Phase III worldwide study of new drug for patients with pancreatic cancer
A new cancer drug combination demonstrated significant improvement in overall survival of late-stage pancreatic cancer patients compared to those receiving standard treatment, according to results of a Phase III clinical trial led by physicians from Scottsdale Healthcare's Virginia G. Cancer Center Clinical Trials, a partnership with the Translational Genomics Research Institute (TGen).
Physicians at the Virginia G. Piper Cancer Center at Scottsdale Healthcare were first to design a clinical trial to determine the safety, tolerability and effectiveness of nab-paclitaxel (Abraxane) in combination with the standard drug gemcitabine in patients with advanced pancreatic cancer. Results of that multicenter study chaired by Dr. Daniel Von Hoff were encouraging enough that it led to one of the largest international studies ever done in pancreatic cancer, with 861 patients.
Full results are expected to be presented at the American Society of Clinical Oncology (ASCO) 2013 Gastrointestinal Cancers Symposium in Jan. 24-26 in San Francisco.
"This is a great example of rapid bench to bedside development of new treatments for cancer. We're ecstatic that we will have a new treatment for patients with late stage pancreatic cancer," said Dr. Von Hoff, international lead investigator and Chief Scientific Officer for the Virginia G. Cancer Center Clinical Trials at Scottsdale Healthcare and TGen's Physician-In-Chief.
The pancreas is a gland behind the stomach that secretes enzymes into the upper part of the small intestine to help digestion. It also produces hormones, including insulin, which helps regulate the metabolism of sugars. Advanced pancreatic cancer is fourth most common cause of cancer death in the United States and throughout the world. It is a difficult to diagnose and treat cancer with the lowest survival rates among all cancer types.
Nab-paclitaxel (Abraxane) is an albumin-bound formulation of paclitaxel, produced by Celgene Corp. Dr. Von Hoff said that results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study will lead Celgene to submit for FDA approval.
"Pancreatic cancer incidence is increasing worldwide with almost 220,000 cases per year, and we are optimistic that this will have worldwide impact for treating advanced pancreatic cancer," added Dr. Ramesh Ramanathan, Medical Director of Virginia G. Cancer Center Clinical Trials at Scottsdale Healthcare and principal investigator for the United States.
Dr. Von Hoff credited the support of Scottsdale Healthcare Foundation, Stand Up to Cancer and the Seena Magowitz Foundation for advancing the study at the Virginia G. Piper Cancer Center at Scottsdale Healthcare. He noted that TGen and International Genomics Consortium scientists in collaboration with scientists from Abraxis Bioscience found that in pancreatic cancer, an albumin-binding protein called SPARC was present at high levels in cells within the pancreatic tumor microenvironment. They hypothesized that the albumin formulation of nab-paclitaxel may be taken up by tumor and surrounding cells with high SPARC expression.
