CP-CTNet Coordinating Center

Cancer is the leading cause of morbidity and mortality in the US and in the world. One approach to reducing the risk and burden of cancer is to use preventive agents and interventions that are effective and safe. According to the Division of Cancer Prevention (DCP) at the National Cancer Institute (NCI), this requires the systematic development of cancer preventive agents and interventions, with three critical components; i) preclinical/toxicology studies for identification of agents through its Cancer Prevention Drug Development Program (PREVENT), ii) early phase trials of identified agents and other promising interventions through the Cancer Prevention Clinical Trials Network (CP-CTNet), and iii) late phase III trials of preventive agents and interventions that have successfully passed through early phase trials in the National Community Oncology Research Program (NCORP), in a three-legged approach. As the second leg of this three-legged approach, CP-CTNet’s overall goal is to efficiently design and conduct early phase clinical trials to assess the safety, tolerability, and cancer preventive potential of a variety of different agents or interventions. Emphasis is on novel agents and interventions that target relevant pathways important in carcinogenesis, to characterize the effects of these agents and interventions on their molecular targets, immune function, and other biological events associated with cancer development (e.g., cell proliferation, apoptosis, growth factor expression, oncogene expression, etc.) and correlate these effects with clinical endpoints, to develop further scientific insights into the mechanism of cancer prevention by the agent or strategy examined and to continue to develop novel potential markers as determinants of response and to facilitate development and conduct of cross-network trials and to speed up preventive agent development. CP-CTNet Sites will perform these early phase trials supported by DCP and the CP-CTNet Data Management, Auditing, and Statistical Center (DMASC). These trials include phase 0 (micro-dosing), phase I (dose-finding), and phase II (preliminary ef f icacy) clinical trials. To support these early phase trials, which will be conducted by CP-CTNet Sites alone or as cross-network trials, CP-CTNet DMASC will coordinate cross-network activities and provide expertise and resources in 1) centralized data management and reporting, 2) clinical trials auditing, 3) statistical support, and 4) administrative and logistical coordination, across CP-CTNet. In addition, CP-CTNet DMASC will provide an advisory role in early phase cancer prevention trial development for all CP-CTNet trials and assume the primary statistical role for supporting cross-network trials.