INTERPERITONEAL THERAPY WITH CISPLATIN/CARBOPLATIN AND FUDR IN OVARIAN CANCER

顺铂/卡铂和 FUDR 腹膜内治疗卵巢癌

• 批准号: 6305913
• 负责人: FRANCO MUGGIA
• 金额: $ 2.1万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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/6305913
• 关键词: carboplatin; cis platinum compound; clinical research; combination chemotherapy; female; floxuridine; human subject; human therapy evaluation; injection /infusion; neoplasm /cancer chemotherapy; ovary neoplasms; peritoneal cavity

Standard treatment of stage-III and -IV ovarian cancer has been surgical resection followed by intravenous paclitaxel and a platinum compound, which stops progression in 80% and results in negative findings in 20% of patients at -second-look+ surgery. When residual disease is detected, therapy is less clear. In pilot studies, intraperitoneal (IP) floxuridine (FUdR) and cisplatin showed encouraging results. Subjects to be entered will be those who have completed stage-I chemotherapy for ovarian cancer but at -second-look+ surgery have > 1 cm peritoneal disease. IP catheters will be placed. FUdR (3g) will be given IP for 3 days, and cisplatin (60 mg/m2) will be given IP on the third day. (When applicable, carboplatin [500 ml] may follow immediately after FUdR.) This treatment cycle will be repeated every 3 weeks. Total duration of treatment will consist of 6 consecutive cycles as long as there is no progression or intolerable toxicity. Subjects will be assessed with a CT scan of the abdomen with IP contrast 6 weeks and one year after therapy or whenever recurrence is suspected. This protocol has been extended to patients with Gi malignancies which have peritoneal spread.

III 期和 IV 期卵巢癌的标准治疗是手术切除，然后静脉注射紫杉醇和铂化合物，可阻止 80% 的进展，并导致 20% 的患者在二次手术中结果呈阴性。 当检测到残留疾病时，治疗就不那么明确了。在初步研究中，腹膜内 (IP) 氟尿苷 (FUdR) 和顺铂显示出令人鼓舞的结果。纳入的受试者将是那些已完成卵巢癌一期化疗但在第二次检查+手术中患有> 1厘米腹膜疾病的患者。将放置 IP 导管。 FUdR (3g) 将腹腔注射 3 天，顺铂 (60 mg/m2) 将在第三天腹腔注射。 （如果适用，可在 FUdR 后立即使用卡铂 [500 ml]。）该治疗周期将每 3 周重复一次。 只要没有进展或无法耐受的毒性，总治疗持续时间将包括 6 个连续周期。治疗后 6 周和一年或怀疑复发时，将使用 IP 造影剂对受试者进行腹部 CT 扫描进行评估。该方案已扩展到腹膜扩散的胃肠道恶性肿瘤患者。