PHASE I DOSE ESCALATION OF MULTIAGENT CHEMOTHERAPY, LEUCOVORIN/GEMZAR

多药化疗（亚叶酸/GEMZAR）的 I 期剂量递增

• 批准号: 6304985
• 负责人: John David Roberts
• 金额: $ 0.06万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304985
• 关键词: clinical research; clinical trial phase I; combination cancer therapy; deoxycytidine; drug administration rate /duration; drug adverse effect; drug screening /evaluation; gemcitabine; human subject; human therapy evaluation; leucovorin; nucleoside analog; outcomes research

A study to evaluate the benefits and side effects of the combination of three drugs, leucovorin, 5FU, and Gemzar, used in chemotherapy for cancer patients. Patients who enter this study have cancer, which has progressed despite standard therapy, or for which there is no standard therapy. All blood work and physical examinations necessary for registration in the study will have been done no longer than seven days before starting. X-rays and scans must be done no more than five weeks before the initial treatment. Registration will take place one week before the start of the treatment. Based on assignment at the time of registration, patients will receive either leucovorin followed by 5FU, which is followed by Gemzar, or they will be randomly assigned to receive Gemzar, then leucovorin, then 5FU. All drugs will be given three times a week for four weeks. Disease assessment will follow the second cycle of therapy unless symptoms prompt earlier assessment. Patients with a complete or partial response or stable disease may be considered for further therapy. Patients continuing therapy will have disease assessment after every two cycles, or about every two months.

一项评估三种药物联合使用的益处和副作用的研究，亚叶酸素，5FU，和Gemzar，用于癌症患者的化疗。参加这项研究的患者患有癌症，尽管接受了标准治疗，但病情仍在恶化，或者没有接受标准治疗。所有研究注册所需的血液检查和身体检查将在开始前不超过7天完成。x光和扫描必须在初始治疗前不超过五周进行。注册将在治疗开始前一周进行。根据注册时的分配，患者将接受亚叶酸钙素和5FU，然后接受Gemzar，或者他们将被随机分配接受Gemzar，然后接受亚叶酸钙素和5FU。所有药物每周服用三次，持续四周。疾病评估将遵循第二周期治疗，除非症状提示早期评估。完全或部分缓解或病情稳定的患者可考虑进一步治疗。继续治疗的患者将在每两个周期或大约每两个月后进行疾病评估。