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Int J Gynecol Cancer. 2013 Nov;23(9):1577-82. doi: 10.1097/IGC.0b013e3182a809e0.

A phase 2 study of oxaliplatin combined with continuous infusion topotecan for patients with previously treated ovarian cancer.

Author information

1
*Division of Medical Oncology, Department of Medicine, Yale School of Medicine, New Haven, CT; †Division of Medical Oncology, Department of Medicine, and ‡Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY; §Beth Israel Cancer Center, Albert Einstein College of Medicine, NY; New York University School of Medicine, New York, NY, ∥Division of Biostatistics, Department of Population Health, New York University School of Medicine, New York, NY; ¶Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD; and #Department of Internal Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA.

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/m(2) day 1 and day 15) and topotecan (0.4 mg/m(2) 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.

PMID:
24172094
PMCID:
PMC3869398
DOI:
10.1097/IGC.0b013e3182a809e0
[Indexed for MEDLINE]
Free PMC Article

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