Encouraging results in early phase pancreatic cancer clinical trial

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Encouraging results in early phase pancreatic cancer clinical trial

Results from a Phase I/II clinical trial of the experimental drug nab-paclitaxel in combination with gemcitabine were published on October 3, 2011 in the prestigious Journal of Clinical Oncology. This study was conducted through Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare in Arizona, a collaboration between Scottsdale Healthcare and Translational Genomics Research Institute (TGen). The study was led by Daniel Von Hoff, MD.

Nab-paclitaxel (Celgene Pharmaceuticals) is an albumin-bound formulation of the chemotherapy drug paclitaxel, with the albumin protein coating designed to specifically bind to a protein that is expressed by pancreatic and other cancer types, but not on the surface of normal cells. Prior to this study, nab-paclitaxel had not been investigated as a treatment for pancreatic cancer. Gemcitabine is the standard of care chemotherapy for pancreatic cancer patients.

The trial described in this paper was designed to determine the appropriate dose of nab-paclitaxel, evaluate the safety of the drug, and provide preliminary evidence of its effectiveness in combination with gemcitabine. The patients who took part in this study had advanced pancreatic cancer and had not previously received any other treatment.

The combination of nab-paclitaxel and gemcitabine was found to cause mild side effects that were deemed tolerable. Encouragingly, the median overall survival of patients treated with this regimen was 12.2 months, compared to approximately six months which is seen historically in advanced pancreatic cancer patients treated with gemcitabine alone. Based on these promising results observed in the early-phase trials, the investigators are embarking on a Phase III trial and currently recruiting patients throughout the US and worldwide.

The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring treatment options. Jordan Berlin, MD, Chair of the organization’s Medical Advisory Board, describes the importance of clinical trials, specifically participation in Phase III trials, here.

The Pancreatic Cancer Action Network’s Patient and Liaison Services (PALS) program maintains a comprehensive database containing up-to-date information about all IRB-approved pancreatic cancer clinical trials taking place in the United States. Information about these clinical trials is available to the public at no charge. To start a personalized clinical trials search, click here or contact a Patient Central Associate toll-free at 877-272-6226 or email patientcentral@pancan.org. Patient Central Associates are available M-F 7am-5pm Pacific Time.

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