The role of the Clinical Trials Core is to provide expertise in the development, implementation andcoordination of all translational clinical trials resultant from the other SPORE projects that will ultimately leadto a better understanding of the biology of lung cancer. This improved understanding will ultimately lead toimprovements in the treatment of lung cancer. To achieve this goal, the major responsibilities of the ClinicalTrials Core will be 1) Provide expertise in the development and implementation of translational clinical trialsrelated to the other SPORE projects 2) Accrual of patients to participate in SPORE initiated trials, 3) Timelyand accurate collection of data, and 4) Accessibility of data for analysis by the various SPORE researchersat Vanderbilt university as well as researchers at other Lung SPORE sites. During the first 1-2 years therewill be 2 - 3 trials open for accrual. These trials will serve to further the scientific knowledge regarding therole of 1) To identify proteomic signatures of lung tumors and serum samples predictive of responsemolecular targeted therapy i.e. EGFR-TKI's and to chemotherapy., 2) To determine the efficacy of docetaxelplus a selective COX-2 inhibitor in recurrent NSCLC exhibiting 'COX dependence'3) Determine the Effect ofPharmacologic 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 predictiveof 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 thisSPORE 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 trialswill be designed based upon the results of the early pilot trials as well as the ongoing research of theparticipating SPORE investigators. The current pilot trials will thus serve as the template for furthertranslational research in lung cancer.
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