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CHAPEL HILL, N.C. – UNC Lineberger Comprehensive Cancer Center will lead a clinical trial to test a new option for colorectal cancer patients whose cancer has not responded to first line therapies.

Almost 40 percent of patients whose cancers test positive for mutant K-RAS or BRAF genes see their cancers continue to progress on the current first line therapies. While monoclonal antibodies targeted toward epithelial growth factor receptors (EGFR) are effective for many colorectal cancer patients, those whose cancers test positive for K-RAS are not candidates for these treatments, which have been shown to be ineffective in the presence of this mutation.

“These patients run out of options faster,” said Richard M. Goldberg, MD, the clinical trial’s principal investigator and associate director for clinical research at UNC Lineberger. “This trial is exciting because it provides another option for advanced disease, the standard chemotherapy regiment plus a new agent called regorafenib.”

According to Goldberg, this is the first study with regorafenib, and the first randomized study of kinase inhibition in combination with chemotherapy to focus on patients with these genetic mutations whose options are limited after their disease progresses on initial treatment. He notes that regorafenib, a multikinase inhibitor, works through a different mechanism than EGFR-targeted treatments. Instead, regorafenib targets a pathway activated by the K-RAS mutation and has the potential to work with chemotherapy to enhance the effects of both drugs against the patient’s cancer.

The study is sponsored by UNC Lineberger and financially supported by Bayer HealthCare AG, which will provide study medication free of charge to patients enrolled on the trial.

The study will be randomized and placebo-controlled, with twice as many patients receiving the experimental treatment as the control treatment of standard chemotherapy for metastatic colorectal cancer. The trial will begin in March 2011 and will enroll a total of 240 patients at UNC and at academic and community sites throughout North Carolina.

To be accepted onto the study, patients must have confirmed K-RAS or BRAF mutations in their tumors and be eligible for second line therapy for metastatic colorectal cancer.

In addition to Goldberg, who serves as chief of the division of hematology/oncology at UNC-Chapel Hill and physician-in-chief of the N.C. Cancer Hospital, other researchers include co-principal investigator Bert O’Neil, MD, Janine Davies, FRCPC, MD, BN, MSc, Stephen Bernard, MD, Tammy Triglianos, NP, and Autumn Jackson McRee, MD.