Adjuvant Biological Therapy for Pancreatic Cancer
Name of the Trial
Phase II Randomized Study of Adjuvant Therapy Comprising Bevacizumab Versus Cetuximab in Combination with Gemcitabine Hydrochloride, Capecitabine, and Radiotherapy in Patients with Completely Resected Carcinoma of the Pancreas (ECOG-E2204). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E2204.
Dr. Jordan Berlin, ECOG; Dr. Arthur William Blackstock, CALGB; Dr. Andrew Lowy, SWOG; and Dr. Robert McWilliams, NCCTG
Why This Trial Is Important
Pancreatic cancer is one of the most deadly types of cancer, with fewer than 4 percent of patients surviving 5 years or longer. The best chance for long-term survival is complete surgical removal (resection) of the tumor. However, even resectable patients face a high likelihood of recurrence. To help improve the outcome for patients with resectable pancreatic cancer, doctors currently treat these patients with postoperative (adjuvant) chemotherapy and radiation therapy.
In this trial, patients with completely resected pancreatic cancer will receive adjuvant chemotherapy and radiation therapy plus additional treatment with either bevacizumab or cetuximab. Bevacizumab and cetuximab are biological agents that target different proteins that are thought to be important for tumor growth and spread. Bevacizumab blocks the activity of vascular endothelial growth factor (VEGF), a protein used by some tumors to form new blood vessels. Cetuximab blocks the activity of epidermal growth factor receptor (EGFR), a protein that promotes cell growth and proliferation.
"Our primary goal with this trial is to assess the safety of these biologic therapies in combination with standard adjuvant treatment," said Dr. Berlin. "Additionally, we hope to see some measures of effectiveness that we can build on in future studies."
Who Can Join This Trial
Researchers will enroll 126 patients with pancreatic cancer that has been completely removed by surgery within the previous 4-8 weeks. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/ECOG-E2204. This trial is eligible for special Medicare coverage.
Study Sites and Contact Information
Study sites in the U.S. are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-E2204 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.