Phase I/II trial of intravenous liposomal doxorubicin and whole abdomen hyperthermia in patients with refractory ovarian cancer.
5089 Background: A phase I/II study of liposomal doxorubicin combined with whole abdominal hyperthermia was conducted in patients with refractory ovarian cancer. Liposomal doxorubicin combined with hyperthermia has been shown to increase liposomal extravasation into tumor xenografts resulting in enhanced cytotoxic effects. METHODS: Thirty patients with either recurrent or persistent epithelial ovarian cancer were enrolled. All patients had either measurable or assessable disease. Patients received intravenous (IV) liposomal doxorubicin 40 mg/m2 as a 1-hour infusion followed by whole abdominal hyperthermia. Quality of life (QOL) was performed at baseline, prior to each cycle, and every 3 months following treatment. RESULTS: All 30 patients were either paclitaxel and/or platinum resistant initially or developed resistant disease. The median number of prior chemotherapeutic regimens was three (range 2-8) and 6 patients had been previously treated with liposomal doxorubicin. There were 3 partial responses for a response rate of 10% and 8 patients (27%) had disease stabilization. The median time to progression was 3.4 months (range, 1.3 to 20.7) and the median survival was 10.8 months (range, 2.7 to 27.2). Twelve patients (40%) experienced palmar-plantar erythrodysesthesia (PPE), but only 4 (13%) experienced grade 3/4 PPE toxicity. None of the patients had grade 3/4 thermal toxicity due to hyperthermia. QOL was stable in patients responding to therapy. CONCLUSIONS: Therapy with intravenous doxorubicin and whole abdominal hyperthermia for patients with platinum/paclitaxel resistant ovarian cancer has modest activity and stabilized quality of life. Whole abdomen hyperthermia was well tolerated in this population. Work supported by a grant from the NIH CA42745. [Table: see text].
Secord, AA; Jones, E; Hahn, CA; Havrilesky, LJ; Soper, JT; Berchuck, A; Clarke-Pearson, DL; Prosnitz, LR; Dewhirst, MW
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