TRIAL OF ICRF-187 TO DECREASE DOXORUBICIN CARDIOMYOPATHY

ICRF-187 减少阿霉素心肌病的试验

• 批准号: 3174153
• 负责人: JAMES SPEYER
• 金额: $ 2.52万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1984
• 资助国家: 美国
• 起止时间: 1984-08-01 至 1988-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3174153
• 关键词: antineoplastics; biopsy; cardiotonic agents; doxorubicin; drug adverse effect; human subject; myocardium disorder

Doxorubicin induced cardiomyopathy limits the cumulative dose of this drug which can be administered to cancer patients. We propose a randomized clinical trial to test the effectiveness of the agent ICRF-187 in preventing this cardiomyopathy in 132 patients with advanced inoperable breast cancer who will be receiving a doxorubicin based combination of cytoxic drugs. ICRF-187 was chosen because in extensive animal studies it consistently prevented the pathologic changes of chronic doxorubicin cardiomyopathy. The drug has also been tested in humans in clinical trials and has been shown to be non-toxic in the doses proposed for this study. All patients will receive 5-fluorouracil, doxorubicin, and cyclophosphamide and will be randomized to receive ICRF-187. The ICRF will be given as an I.V. bolus 30 minutes prior to the administration of doxorubicin. Patients will be monitored for acute toxicity to the hemotherapeutic agents by clinical examination, blood examinations and x-rays. The primary endpoint of the study is the development of cardiotoxicity which will be assessed by clinical examination, falls in left ventricular ejection fractions as measured by resting and exercise nuclear gated pool scans and pathologic changes seen in right ventricular endomyocardial biopsies. Biopsies will be done in 36 patients.

阿霉素诱导的心肌病限制了该药的累积剂量 其可以被施用给癌症患者。 我们提出了一个随机的 一项临床试验，以测试ICRF-187制剂在 在132例晚期不可手术的患者中预防这种心肌病 将接受基于阿霉素的联合治疗的乳腺癌患者， 细胞毒性药物 选择ICRF-187是因为在广泛的动物研究中， 持续防止慢性阿霉素的病理变化 心肌病 该药物也在临床试验中进行了人体试验 并且已经证明在本研究所建议的剂量下无毒。 所有患者将接受5-氟尿嘧啶、阿霉素和环磷酰胺治疗 并随机接受ICRF-187治疗。 ICRF将作为一个 在给予多柔比星前30分钟静脉推注。 将监测患者对止血剂的急性毒性 通过临床检查、血液检查和X光检查。 该研究的主要终点是心脏毒性的发展 将通过临床检查进行评估，左心室福尔斯 通过静息和运动核门控池测量射血分数 右室心肌内膜异位症的扫描和病理改变 活组织检查 将对36名患者进行活检。