Emory Winship Cancer Institute will be the first cancer research and treatment facility in the country to open a clinical trial testing a new combination of chemopreventive drugs for head and neck cancer. Studying premalignant lesions of the oral cavity and larynx in former smokers, researchers will use the drug combination of erlotinib and celecoxib to block epidermal growth factor receptor (EGFR) mediated signaling and to inhibit cyclooxygenase-2 (COX-2) mediated pathways.
Erlotinib is a drug that blocks EGFR tyrosine kinase protein messaging, which tells cancer cells to grow and divide, and celecoxib is an anti-inflammatory drug that reduces cell formation, blood vessel formation, and metastases. Individually the drugs have been found to be effective chemopreventive agents.
Preclinical studies evaluating the combination of erlotinib and celecoxib have demonstrated positive results in suppressing the production activity of EGFR and COX-2 and effective inhibition of tumor growth in test tubes and animal models. EGFR is a key protein that has been targeted as a source in the development and rapid multiplication of cancer cells, and COX-2 is an enzyme, which in high levels also contributes to tumor growth activity.
The goals of the clinical study are to evaluate the safety and effectiveness of the chemopreventive drug combination therapy, to determine whether selected biomarkers involved in EGFR-mediated signaling and COX-2 pathways are aberrantly expressed in premalignant lesions and cancer-exposed normal buccal mucosa inside the cheeks, and to determine whether the proposed biomarkers are affected by the combined treatment.
The American Cancer Society estimates that there will be 29,370 newly diagnosed cancer cases of the oral cavity/pharynx and 9,880 of the larynx in the United States this year. Additionally, there will be more than 10,000 deaths from both cancer sites combined.
The principal investigator on the study is Dong M. Shin, MD, Professor of Hematology and Oncology and Otolaryngology, and Co-Director of the Lung Cancer and Aerodigestive Tract Malignancies Program at Emory Winship Cancer Institute. "There are no standard approaches to prevent head and neck cancer at present," said Dr. Shin. "We are seeking to develop a more effective way of prevention of this disease, and the drug combination therapy of erlotinib and celecoxib will be an excellent approach for chemoprevention. It will only be available through participation in a clinical trial."
Dr. Shin noted that the chemopreventive study is promising where chemotherapy alone has not been successful in the prevention of such a deadly disease. "While much more work needs to be done in this area, we hope that our study on the drug combination therapy will make a major impact. This may prevent second primary tumors in early stage of the disease, which are a major failure pattern in this specific population," said Dr. Shin.
For more information on this clinical trial, contact Martha Forrester, RN, Research Nurse, at 404-778-5849.