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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项单中心、I/II期研究，研究顺铂或卡铂和阿糖胞苷（FUdR）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控制。 PI在南加州大学和纽约大学的初步工作验证了这种方法。 本研究的主要目的是评估由铂和FUdR组成的IP药物方案治疗妇科或GI恶性肿瘤（仅限于腹膜的微小残留病变）的毒性、耐受性和完成率。 次要目的是确定失败的部位，并估计IP方案后的至失败时间和生存时间。 该方案的目标之一也是确定疾病进展的预后因素，并在开始治疗前对腹膜进行腹腔镜检查，以确定残留疾病的程度。 将对CA-125阳性患者进行该标志物应答的随访。 发生神经或肾毒性的患者将酌情从顺铂转换为卡铂。