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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项单点I/II期研究，采用顺铂或卡铂和氟尿嘧啶(FUDR)作为巩固治疗卵巢和胃肠道恶性肿瘤的腹膜腔内(IP)疗法。该方案源于过去10-12年的观察结果，即卵巢癌患者的IP治疗实现了对复发疾病的局部区域控制。南加州大学和纽约大学PI的初步工作证实了这一方法。这项研究的主要目的是评估由铂和氟尿嘧啶组成的IP药物方案对仅限于腹膜的微小残留病变的妇科或胃肠道恶性肿瘤的毒性、耐受性和完成率。第二个目标是确定失败的位置，并估计失败的时间和这种IP方案后的生存时间。该方案还将确定疾病进展的预后因素和在开始治疗之前对腹膜进行腹腔镜检查以确定残留疾病的程度作为其目标之一。CA-125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转向卡铂。

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.