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Twelve patients with operable, recurrent platinum\u2010sensitive EOC (recurrence \u22656 months after first\u2010line therapy) were included according to the classical 3+3 dose\u2010escalation design at three dose levels\u201460, 80 and 100 mg\/m<jats:sup>2<\/jats:sup>. After surgical cytoreduction, a single dose of cisplatin was administered <jats:italic>via<\/jats:italic> HIPEC for 90 min at 41\u201343\u00b0C. Postoperatively, all patients were treated with standard intravenous platinum\u2010based combination chemotherapy. One of six patients experienced a dose\u2010limiting toxicity (grade 3 renal toxicity) at a dose of 100 mg\/m<jats:sup>2<\/jats:sup>. The remaining five patients treated with 100 mg\/m<jats:sup>2<\/jats:sup> tolerated their treatment well. The recommended phase II dose was established at 100 mg\/m<jats:sup>2<\/jats:sup>. The mean peritoneal\u2010to\u2010plasma AUC ratio was 19\u00b75 at the highest dose level. Cisplatin\u2010induced DNA adducts were confirmed in tumor samples. Common postoperative grade 1\u20133 toxicities included fatigue, postoperative pain, nausea, and surgical site infection. The ability to administer standard intravenous platinum\u2010based chemotherapy after HIPEC was uncompromised. Cisplatin administered as HIPEC at a dose of 100 mg\/m<jats:sup>2<\/jats:sup> has an acceptable safety profile in selected patients undergoing secondary cytoreductive surgery for platinum\u2010sensitive recurrent EOC. Favorable pharmacokinetic and pharmacodynamic properties of HIPEC with cisplatin were confirmed at all dose levels, especially at 100 mg\/m<jats:sup>2<\/jats:sup>. The results are encouraging to determine the efficacy of HIPEC as a complementary treatment in patients with EOC.<\/jats:p>","DOI":"10.1002\/ijc.29011","type":"journal-article","created":{"date-parts":[[2014,6,4]],"date-time":"2014-06-04T10:03:28Z","timestamp":1401876208000},"page":"699-708","source":"Crossref","is-referenced-by-count":83,"title":["HIPEC ROC I: A phase i study of cisplatin administered as hyperthermic intraoperative intraperitoneal chemoperfusion followed by postoperative intravenous platinum\u2010based chemotherapy in patients with platinum\u2010sensitive recurrent epithelial ovarian cancer"],"prefix":"10.1002","volume":"136","author":[{"given":"Oliver","family":"Zivanovic","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology University Hospital Bonn Bonn Germany"},{"name":"Gynecology Service, Department of Surgery Memorial Sloan Kettering Cancer Center  NY, USA"},{"name":"Center for Integrated Oncology Cologne Bonn University Hospitals 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