COOPERATIVE STUDY

本申请书是代表芝加哥大学提交的， 由伊利诺伊州的三家附属社区医院和 印第安纳州。这项建议的目的是研究新的第二阶段药物在 标准疗法难以治愈的实体肿瘤的治疗 包括乳腺癌，非小细胞肺癌，前列腺癌， 结直肠癌、头颈部癌和肾癌。这些研究 寻求建立新的药物在这些疾病中的活性。此外, 我们建议对其群体药代动力学和药效学进行研究。 抗癌单剂和/或组合物，并测定其 对治疗结果的意义，包括毒性和反应。我们 将寻求开发药理模型，以优化治疗 抗癌药物的比例和协助个体化给药。这个 拟议的研究将在芝加哥大学和三所大学进行 附属医院。这些机构以前曾合作过 并在进行多机构临床治疗方面有良好的记录 研究。预计将对多达40名患者进行四项Il期试验 每一次都将在这个联合体内每年进行一次。在……里面 此外，还有坚实的药理学制度基础 基于新型抗癌药物的临床研究。协议示例 用于吡嗪重氮氢氧化物或苏拉明的II期试验 乳腺癌、结直肠癌、前列腺癌、非小细胞肺癌和肾癌， 分别进行了分析。关于伴随的附加示例协议 本发明提供了一种头颈部癌症的放化疗。在其中的每一个中 研究一种新的单一药物或联合药物的临床活性 将对接受最低限度预治疗的患者群体进行调查。此外, 将建立详细的动力学和药效学资料。

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.