Duke-UNC-Wash U Partnership for Early Phase Clinical Trials in Cancer

Duke University, Durham NC

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): The ETCTN is poised to provide break-through advances in our management of cancer. Our understanding of basic cancer biology, the availability of novel diagnostics to measure this biology, and the availability of novel targeted therapies to impact that biology are now at a point that has been previously un-imaginable. The pace of these advances is now increasing exponentially, particularly with successes in immunotherapies and target therapies in molecularly defined patient populations. Given these paradigm-changing advances, the ETCTN is restructuring to provide a more efficient and integrated assessment of toxicity, efficacy, and biomarker endpoints throughout the continuum of early stage Phase I/Phase II clinical trials. In support of this mission, the Duke Cancer Institute, the Lineberger Comprehensive Cancer Center at UNC, and the Siteman Cancer Center at Washington University (DUNCWU) have committed to extending their strategic Partnership in early oncology drug development to include the Phase II goals of the ETCTN. The Duke-UNC-Wash U Partnership will bring together 3 of the nation's most pre-eminent cancer centers. Our Partnership provides world class breadth and depth, both clinically and scientifically, to meet both the Phase I and Phase II goals of the ET-CTN. Combined, this partnership manages over 19,000 new cancer cases per year, and enrolls over 2,400 new patients onto phase II clinical trials similar to the ones envisioned by the ETCTN. Each center has a large phase II program lead by highly experienced clinical researchers and staff. Each center has both the clinical expertise and the clinical volumes needed for the study of novel agents targeting niche populations. There is particular expertise in the management of multi-center studies and the analysis of biomarkers on these studies. Our Partnership provides world class expertise in genomics, proteomics, immune monitoring, angiogenesis, and pharmacogenomics, using both unbiased and focused approaches. The Duke-UNC-Wash U Partnership will implement these overarching goals by the following specific steps: (1) establishing world class Phase II disease based and translational teams that are collaborative and team- science oriented; (2) developing novel plans of attack for the development of novel anti-cancer agents and combination regimens; (3) executing efficiently on the development of formal proposals and protocols; (4) effectively managing studies under Duke UNC Wash U Partnership and accruing rapidly to all ETCTN studies; and (5) translating this information, both bench-to-bedside and bedside-to-bench. Particular emphasis will be placed upon novel therapies and combinations that target specific genetic alterations, host immune responses, angiogenesis and other stromal responses, and cancer stem cells. Taken together, the Duke-UNC-Wash U Partnership is committed and ideally suited to realizing the goals of the ET-CTN to more rapidly translate novel science into more effective cancer therapies.