COOPERATIVE STUDY

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This application is submitted on behalf of the University of Chicago and a consortium of three affiliated community hospitals in Illinois and Indiana. The aims of this proposal are to study new phase II agents in the treatment of solid tumors that are refractory to standard therapy including breast cancer, non-small cell lung cancer, prostate cancer, colorectal cancer head and neck cancer and renal cancer. These studies seek to establish activity of new agents in these diseases. In addition, we propose to study population pharmacokinetics and pharmacodynamics of anticancer single agents and/or combinations, and to determine their significance for treatment outcome including toxicity and response. We will seek to develop pharmacologic models that optimize the therapeutic ratio of anticancer agents and assist in individualized dosing. The proposed studies will be conducted at the University of Chicago and three affiliated hospitals. These institutions have previously worked together and have a firm track record of conducting multiinstitutional clinical research. It is expected that four phase Il trials of up to 40 patients each will be conducted on an annual basis within this consortium. In addition there is a solid institutional foundation of pharmacologically based clinical investigations of new anticancer agents. Sample protocols are provided for phase II trials of pyrazine diazo hydroxide or suramin in breast, colorectal, prostate, non-small cell lung and renal cancer, respectively. An additional sample protocol on concomitant chemoradiotherapy in head and neck cancer is provided. In each of these studies clinical activity of a new single agent or combination in a minimally pretreated patient population will be investigated. In addition, a detailed kinetic and pharmacodynamic profile will be established.