The role of the Clinical Trials Core is to provide expertise in the development, implementation and coordination of all translational clinical trials resultant from the other SPORE projects that will ultimately lead to a better understanding of the biology of lung cancer. This improved understanding will ultimately lead to improvements in the treatment of lung cancer. To achieve this goal, the major responsibilities of the Clinical Trials Core will be 1) Provide expertise in the development and implementation of translational clinical trials related to the other SPORE projects 2) Accrual of patients to participate in SPORE initiated trials, 3) Timely and accurate collection of data, and 4) Accessibility of data for analysis by the various SPORE researchers at Vanderbilt university as well as researchers at other Lung SPORE sites. During the first 1-2 years there will be 2 - 3 trials open for accrual. These trials will serve to further the scientific knowledge regarding the role of 1) To identify proteomic signatures of lung tumors and serum samples predictive of response molecular targeted therapy i.e. EGFR-TKI's and to chemotherapy., 2) To determine the efficacy of docetaxel plus a selective COX-2 inhibitor in recurrent NSCLC exhibiting """"""""COX dependence""""""""3) Determine the Effect of Pharmacologic Inhibitor as Single Agent in Patients with Advanced, Refractory Non-small Cell Lung Cancer. 4) To determine if SAHA inhibits HDAC activity in patients and to test candidate molecular profiles predictive of clinical response or lack of response to SAHA. Over the five year course of the SPORE grant, trials will open and close. One of the goals of this SPORE is that the successful completion of these early pilot trials will ultimately lead on to larger scale, multi-institution trials for confirmation of our results. A second goal is that additional translational clinical trials will be designed based upon the results of the early pilot trials as well as the ongoing research of the participating SPORE investigators. The current pilot trials will thus serve as the template for further translational research in lung cancer.
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