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

Research output: Contribution to journalArticle

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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. / Dark, GG; Calvert, AH; Grimshaw, R; Poole, Christopher; 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, EA.

In: Journal of Clinical Oncology, Vol. 23, No. 9, 07.02.2005, p. 1859-1866.

Research output: Contribution to journalArticle

Harvard

Dark, GG, Calvert, AH, 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, EA 2005, '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', Journal of Clinical Oncology, vol. 23, no. 9, pp. 1859-1866. https://doi.org/10.1200/JCO.2005.02.028

APA

Dark, GG., Calvert, AH., 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, EA. (2005). 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. Journal of Clinical Oncology, 23(9), 1859-1866. https://doi.org/10.1200/JCO.2005.02.028

Vancouver

Author

Dark, GG ; Calvert, AH ; Grimshaw, R ; Poole, Christopher ; 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, EA. / 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. In: Journal of Clinical Oncology. 2005 ; Vol. 23, No. 9. pp. 1859-1866.

Bibtex

@article{0cc764b507c64e4eb71835ab15b9b346,
title = "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",
abstract = "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/m(2)/d administered by 30-minute intravenous infusion on days 1, 2, and 3 every 3 weeks) or arm B (OSI-211 2.4 mg/m(2)/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.",
author = "GG Dark and AH Calvert and R Grimshaw and Christopher Poole and K Swenerton and S Kaye and R Coleman and G Jayson and T Le and S Ellard and M Trudeau and P Vasey and M Hamilton and T Cameron and E Barrett and W Walsh and L McIntosh and EA Eisenhauer",
year = "2005",
month = feb,
day = "7",
doi = "10.1200/JCO.2005.02.028",
language = "English",
volume = "23",
pages = "1859--1866",
journal = "Journal of Clinical Oncology ",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "9",

}

RIS

TY - JOUR

T1 - 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

AU - Dark, GG

AU - Calvert, AH

AU - Grimshaw, R

AU - Poole, Christopher

AU - Swenerton, K

AU - Kaye, S

AU - Coleman, R

AU - Jayson, G

AU - Le, T

AU - Ellard, S

AU - Trudeau, M

AU - Vasey, P

AU - Hamilton, M

AU - Cameron, T

AU - Barrett, E

AU - Walsh, W

AU - McIntosh, L

AU - Eisenhauer, EA

PY - 2005/2/7

Y1 - 2005/2/7

N2 - 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/m(2)/d administered by 30-minute intravenous infusion on days 1, 2, and 3 every 3 weeks) or arm B (OSI-211 2.4 mg/m(2)/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.

AB - 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/m(2)/d administered by 30-minute intravenous infusion on days 1, 2, and 3 every 3 weeks) or arm B (OSI-211 2.4 mg/m(2)/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.

U2 - 10.1200/JCO.2005.02.028

DO - 10.1200/JCO.2005.02.028

M3 - Article

C2 - 15699482

VL - 23

SP - 1859

EP - 1866

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 9

ER -