TRIAL OF ICRF-187 TO DECREASE DOXORUBICIN CARDIOMYOPATHY

阿霉素引起的心肌病限制了该药的累积剂量 它可以用于癌症患者。我们提出了一个随机化的 ICRF-187药剂在临床试验中的疗效 132例晚期不能手术患者心肌病的预防 乳腺癌患者将接受基于阿霉素的联合治疗 毒杀细胞药物。之所以选择ICRF-187是因为在广泛的动物研究中 始终如一地预防慢性阿霉素的病理变化 心肌病。该药物也已在人体上进行了临床试验。 并已被证明在本研究建议的剂量下是无毒的。 所有患者将接受5-氟尿嘧啶、阿霉素和环磷酰胺的治疗。 并将被随机接受ICRF-187。ICRF将作为一项 阿霉素注射前30分钟静脉推注。 将监测患者对血液治疗药物的急性毒性 通过临床检查、血液检查和X光检查。 这项研究的主要终点是心脏毒性的发展 这将通过临床检查来评估，落在左心室 静息和运动核门池法测定射血分数 右室心内膜心肌的扫描和病理改变 活组织检查。36名患者将接受活组织检查。

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.