Name of the Trial
Phase II Study of Sorafenib and Cetuximab in Patients with Epidermal Growth Factor Receptor-Expressing Metastatic Colorectal Cancer (NCI-06-C-0164). See the protocol summary at http://cancer.gov/clinicaltrials/NCI-06-C-0164.

Principal Investigator
Dr. Shivaani Kummar, NCI’s CCR

Why This Trial Is Important
Many types of cancer show increased activity or increased amounts of a protein called epidermal growth factor receptor (EGFR). EGFR stimulates cell growth and multiplication in response to other proteins called epidermal growth factors. Cetuximab (Erbitux) is a monoclonal antibody that binds to and blocks EGFR activity.

In this trial, researchers are combining cetuximab with another targeted drug called sorafenib (Nexavar) to treat patients with metastatic colorectal cancer whose tumors show EGFR activity. Sorafenib blocks the activity of two other proteins called vascular endothelial growth factor receptor (VEGFR) and Raf kinase. VEGFR stimulates the growth of blood vessels to tumors (a process called angiogenesis), and Raf kinase is a key molecule in relaying signals from growth factor receptors to the interior of the cell, where the signals are converted into changes in gene activity that lead to cell growth and multiplication.

“The majority of patients with metastatic colorectal cancer have tumors expressing EGFR,” said Dr. Kummar. “Cetuximab is approved by the FDA to treat EGFR-expressing metastatic colorectal cancer, but unfortunately, it produces significant tumor shrinkage in only about 10 percent of patients when used as a single agent. With this trial, we hope to see an improved response rate by augmenting the activity of cetuximab with an additional drug that blocks other processes important for tumor growth and cell proliferation.”

Who Can Join This Trial
Researchers seek to enroll 53 patients aged 18 or over with metastatic colorectal cancer that tests positive for EGFR. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NCI-06-C-0164.

Study Site and Contact Information
This study is taking place at the NIH Clinical Center in Bethesda, Md. For more information, call the NCI Clinical Studies Support Center at 1-888-NCI-1937. The call is toll free and confidential.