IP THERAPY WITH CISPLATIN OR CARBOPLATIN AND FLOXURIDINE FOR OVARIAN & GI CANCER

顺铂或卡铂联合氟尿嘧啶治疗卵巢

• 批准号: 7605769
• 负责人: FRANCO MUGGIA
• 金额: $ 0.51万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605769
• 关键词: CA-125 Antigen; Carboplatin; Carboplatin/Floxuridine; Cisplatin; Computer Retrieval of Information on Scientific Projects Database; Disease Progression; Failure; Floxuridine; Funding; Goals; Grant; Gynecologic; Institution; Kidney; Malignant Neoplasms; Malignant neoplasm of ovary; Ovarian; Patients; Peritoneum; Pharmaceutical Preparations; Phase; Platinum; Prognostic Factor; Protocols documentation; Rate; Recurrent disease; Research; Research Personnel; Residual Neoplasm; Residual Tumors; Resources; Site; Source; Time; Toxic effect; Treatment Protocols; United States National Institutes of Health; Work; gastrointestinal; improved; intraperitoneal; intraperitoneal therapy; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a single-site, phase I/II study of intraperitoneal (IP) therapy with cisplatin or carboplatin and floxuridine (FUdR) as consolidation for ovarian and gastrointestinal malignancies. The protocol arises from observations over the last 10-12 years that IP treatment of patients with ovarian cancer achieved improved loco-regional control of recurrent disease. Preliminary work by the PI at USC and at NYU validates this approach. The primary objective of the study is to assess the toxicity, tolerance and completion rate of an IP drug regimen consisting of platinum and FUdR for gynecologic or GI malignancies with minimal residual disease confined to the peritoneum. A secondary objective is to determine the sites of failure and to estimate the time to failure and survival time following such an IP regimen. The protocol also has as one of its goals the determination of prognostic factors for disease progression and laparoscopic inspection of the peritoneum to determine the extent of residual disease prior to initiation of treatment. Patients with positive CA-125 will be followed for the response of that marker. Patients who develop neuro or renal toxicity will be switched from cisplatin to carboplatin as appropriate.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项单中心 I/II 期研究，采用顺铂或卡铂和氟尿苷 (FUdR) 进行腹腔内 (IP) 治疗，作为卵巢和胃肠道恶性肿瘤的巩固治疗。 该方案源于过去 10-12 年的观察结果，即卵巢癌患者的 IP 治疗改善了复发性疾病的局部区域控制。 南加州大学和纽约大学的 PI 的初步工作验证了这种方法。 该研究的主要目的是评估由铂类和 FUdR 组成的 IP 药物治疗方案对于仅限于腹膜的微小残留病的妇科或胃肠道恶性肿瘤的毒性、耐受性和完成率。 次要目标是确定故障部位并估计此类 IP 方案后的故障时间和生存时间。 该方案的目标之一还包括确定疾病进展的预后因素以及腹腔镜检查腹膜以确定开始治疗前残留疾病的程度。 CA-125 呈阳性的患者将被跟踪观察该标志物的反应。 出现神经或肾毒性的患者将酌情从顺铂改为卡铂。