COOPERATIVE STUDY

合作学习

• 批准号: 6315467
• 负责人: EVERETT E. VOKES
• 金额: $ 32.05万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-06-01 至 2001-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6315467
• 关键词: antineoplastics; breast neoplasms; clinical trials; colorectal neoplasms; combination cancer therapy; cooperative study; dosage; drug adverse effect; drug resistance; drug screening /evaluation; gas chromatography; head /neck neoplasm; high performance liquid chromatography; human subject; human therapy evaluation; kidney neoplasms; neoplasm /cancer chemotherapy; neoplasm /cancer radiation therapy; neoplasm /cancer relapse /recurrence; nonsmall cell lung cancer; pharmacokinetics; statistics /biometry

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.

本申请是代表芝加哥大学提交的，并且 由伊利诺伊州三个附属社区医院组成的联盟 印第安纳州。该提案的目的是研究新的 II 期药物 治疗标准疗法难治的实体瘤 包括乳腺癌、非小细胞肺癌、前列腺癌、 结直肠癌、头颈癌和肾癌。这些研究 寻求建立新药物对这些疾病的活性。此外， 我们建议研究群体药代动力学和药效学 抗癌单一药物和/或组合，并确定它们的 对治疗结果（包括毒性和反应）具有重要意义。我们 将寻求开发优化治疗的药理学模型 抗癌药物的比例并协助个体化剂量。这 拟议的研究将在芝加哥大学和三个 附属医院。这些机构此前曾合作过 并拥有进行多机构临床的良好记录 研究。预计将进行四项 II 期试验，涉及多达 40 名患者 每项活动都将在该联盟内每年进行一次。在 此外，还有坚实的药理学机构基础 基于新抗癌药物的临床研究。协议样本 提供用于吡嗪氢氧化重氮或苏拉明的 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。伴随的附加样本协议 提供头颈癌的放化疗。在这些中的每一个中 研究新的单药或组合的临床活性 将调查最低限度预处理的患者群体。此外， 将建立详细的动力学和药效学特征。

项目成果

Pharmacokinetics and pharmacodynamics of 9-aminocamptothecin infused over 72 hours in phase II studies.

II 期研究中输注 72 小时以上 9-氨基喜树碱的药代动力学和药效学。

• 发表时间: 1999
• 期刊: Clinical cancer research : an official journal of the American Association for Cancer Research
• 作者: Minami,H;Lad,TE;Nicholas,MK;Vokes,EE;Ratain,MJ
• 通讯作者: Ratain,MJ

A phase II trial of 9-aminocaptothecin (9-AC) as a 120-h infusion in patients with non-small cell lung cancer.

对非小细胞肺癌患者进行 9-氨基辣椒碱 (9-AC) 120 小时输注的 II 期试验。

• DOI: 10.1023/a:1010674113243
• 发表时间: 2001
• 期刊: Investigational new drugs
• 影响因子: 3.4
• 作者: Vokes,EE;Gordon,GS;Rudin,CM;Mauer,AM;Watson,S;Krauss,S;Arrieta,R;Golomb,HM;Hoffman,PC
• 通讯作者: Hoffman,PC

Phase II and pharmacodynamic studies of pyrazine diazohydroxide (NSC 361456) in patients with advanced renal and colorectal cancer.

重氮基吡嗪 (NSC 361456) 在晚期肾癌和结直肠癌患者中的 II 期和药效学研究。

• 发表时间: 1998
• 期刊: Clinical cancer research : an official journal of the American Association for Cancer Research
• 作者: Vogelzang,NJ;Mani,S;Schilsky,RL;Ansari,RH;Taber,D;Rhinehart,SN;Garcia,JC;Meyer,SC;Mick,R;Brockstein,BE;Stadler,WM;Ratain,MJ;Vokes,EE
• 通讯作者: Vokes,EE

Phase II trial of uracil/tegafur (UFT) plus leucovorin in patients with advanced biliary carcinoma.

尿嘧啶/替加氟 (UFT) 加亚叶酸治疗晚期胆管癌患者的 II 期试验。

• DOI: 10.1023/a:1006268018519
• 发表时间: 1999
• 期刊: Investigational new drugs
• 影响因子: 3.4
• 作者: Mani,S;Sciortino,D;Samuels,B;Arrietta,R;Schilsky,RL;Vokes,EE;Benner,S
• 通讯作者: Benner,S

Limited sampling model for area under the concentration time curve of total topotecan.

总拓扑替康浓度时间曲线下面积的有限采样模型。

• 发表时间: 1996
• 期刊: Clinical cancer research : an official journal of the American Association for Cancer Research.
• 作者: Minami,H;Beijnen,JH;Verweij,J;Ratain,MJ
• 通讯作者: Ratain,MJ