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International Journal of Gynecological Cancer:
doi: 10.1097/IGC.0b013e3182a809e0
Ovarian Cancer

A Phase 2 Study of Oxaliplatin Combined With Continuous Infusion Topotecan for Patients With Previously Treated Ovarian Cancer

Stein, Stacey M. MD*; Tiersten, Amy MD; Hochster, Howard S. MD*; Blank, Stephanie V. MD; Pothuri, Bhavana MD; Curtin, John MD; Shapira, Ilan MD§; Levinson, Benjamin PhD; Ivy, Percy MD; Joseph, Benson MD; Guddati, Achuta Kumar MD, PhD#; Muggia, Franco MD

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Abstract

Background: Phase 2 trials suggest that prolonged intravenous (IV) infusion of the topoisomerase 1 inhibitor topotecan may be less toxic than when given by standard IV bolus 5-day administration. Oxaliplatin exhibits efficacy in platinum-pretreated disease and shows preclinical synergy with topoisomerase 1 inhibitors. We sought to determine the efficacy and safety of oxaliplatin plus infusion topotecan in recurrent platinum-pretreated ovarian cancer.

Methods: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancers previously treated with 1 to 2 prior regimens including platinum and taxane received oxaliplatin (85 mg/m2 day 1 and day 15) and topotecan (0.4 mg/m2 per day) by continuous IV infusion over 14 days every 4 weeks. The primary objective of the trial was to estimate the objective response rate in platinum-resistant disease (stratum 1) and in platinum-sensitive disease (stratum 2). Toxicities were assessed in all patients.

Results: Thirty-eight patients received 144 cycles of therapy (median, 4; range, 1–6). The most common grade 3 and grade 4 toxicities included thrombocytopenia (grade 3, 37%; and grade 4, 19%), neutropenia (grade 3, 37%; grade 4, 11%), and anemia (grade 3, 15%). Response occurred in 4 of 19 patients in stratum I (21%; 95% confidence intervals, 6%–46%) and 9 of 19 patients in stratum 2 (47%; 95% CI, 24%–71%). Three in each stratum had lengthy complete responses.

Conclusions: Biweekly oxaliplatin plus a 14-day continuous IV infusion of topotecan, given monthly, is an active regimen in platinum-pretreated ovarian cancer and merits additional evaluation.

© 2013 by the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology.

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