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Randomized trial of two intravenous schedules of the topoisomerase I inhibitor liposomal lurtotecan in women with relapsed epithelial ovarian cancer: A trial of the national cancer institute of Canada clinical trials group

Lookup NU author(s): Dr Graham Dark, Professor Alan Calvert


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Purpose: Liposomal lurtotecan (OSI-211) is a liposomal formulation of the water-soluble topoisomerase I inhibitor lurtotecan (GI147211), which demonstrated superior levels of activity compared with topotecan in preclinical models. We studied two schedules of OSI-211 in a randomized design in relapsed ovarian cancer to identify the more promising of the two schedules for further study. Patients and Methods: Eligible patients had measurable epithelial ovarian, fallopian, or primary peritoneal cancer that was recurrent after one or two prior regimens of chemotherapy. Patients were randomly assigned to receive either arm A (OSI-211 1.8 mg/m2/d administered by 30-minute intravenous infusion on days 1, 2, and 3 every 3 weeks) or arm B (OSI-211 2.4 mg/m2/d administered by 30-minute intravenous infusion on days 1 and 8 every 3 weeks). The primary outcome measure was objective response, which was confirmed by independent radiologic review, and a pick the winner statistical design was used to identify the schedule most likely to be superior. Results: Eighty-one patients were randomized between October 2000 and September 2001. The hematologic toxic effects were greater on arm A than on arm B (grade 4 neutropenia, 51% v 22%, respectively), as was febrile neutropenia (26% v 2.4%, respectively). Of the 80 eligible patients, eight patients (10%) had objective responses; six responders (15.4%; 95% CI, 6% to 30%) were in arm A and two responders (4.9%; 95% CI, 1% to 17%) were in arm B. Conclusion: The OSI-211 daily for 3 days intravenous schedule met the statistical criteria to be declared the winner in terms of objective response. This schedule was also associated with more myelosuppression than the schedule of OSI-211 administered in arm B. © 2005 by American Society of Clinical Oncology.

Publication metadata

Author(s): Dark, G., Calvert, A. H., Grimshaw, R., Poole, C., Swenerton, K., Kaye, S., Coleman, R., Jayson, G., Le, T., Ellard, S., Trudeau, M., Vasey, P., Hamilton, M., Cameron, T., Barrett, E., Walsh, W., McIntosh, L., Eisenhauer, E.

Publication type: Article

Publication status: Published

Journal: Journal of Clinical Oncology

Year: 2005

Volume: 23

Issue: 9

Pages: 1859-1866

Print publication date: 20/03/2005

ISSN (print): 0732-183X

ISSN (electronic): 1527-7755


DOI: 10.1200/JCO.2005.02.028

PubMed id: 15699482


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