PHASE I TRIAL OF SUBCUTANEOUS CALCITRIOL AND CARBOPLATIN IN ADVANCED SOLID TUMOR

皮下骨化三醇和卡铂治疗晚期实体瘤的 I 期试验

• 批准号: 6275861
• 负责人: DAVID TRUMP
• 金额: $ 1.91万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6275861
• 关键词: 1,25 dihydroxycholecalciferol; carboplatin; clinical research; clinical trial phase I; combination cancer therapy; dosage; drug administration routes; drug adverse effect; drug interactions; human subject; human therapy evaluation; metastasis; neoplasm /cancer chemotherapy; neoplasm /cancer classification /staging; nutrition related tag; vitamin therapy

The aims of this trial are to assess the toxicities of and determine the maximum tolerated dose (MTD) of subcutaneous calcitriol given Day 1-5 in combo with carboplatin (AUC=6) Day 5; to assess the toxicities of and determine the maximum tolerated dose (MTD) of carboplatin Day 5 when given with subcutaneous calcitriol Day 1-5 at a dose one dosage level less than the MTD; to determine the effect of administration of calcitriol on the AUC of carboplatin; and to assess the relationship between the AUC of carboplatin and myelosuppression.

本试验的目的是评估毒性并确定 皮下给予骨化三醇的最大耐受剂量（MTD） 联合卡铂（AUC=6）第5天;评估毒性， 确定第5天给予卡铂时的最大耐受剂量（MTD） 第1-5天皮下注射骨化三醇，剂量水平小于 MTD;以确定骨化三醇给药对 卡铂的AUC;并评估卡铂的AUC与 卡铂和骨髓抑制