Single-dose intravenous casopitant in combination with ondansetron and dexamethasone for the prevention of oxaliplatin-induced nausea and vomiting: a multicenter, randomized, ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2011-08-07

AUTHORS

Paul J. Hesketh, Oliver Wright, Gerardo Rosati, Mark Russo, Jeremey Levin, Stephen Lane, Vladimir Moiseyenko, Pierre Dube, Mikhail Kopp, Anatoly Makhson

ABSTRACT

PurposeThe primary objective was to determine if a single dose of casopitant 90 mg added to ondansetron and dexamethasone would improve the control of chemotherapy-induced nausea and vomiting (CINV) over 0–120 h following initiation of oxaliplatin-based moderately emetic chemotherapy (MEC) compared to ondansetron and dexamethasone alone.MethodsPatients with colorectal cancer received either casopitant or placebo intravenously (IV) added to ondansetron 8 mg bid oral on study days 1 to 3 and one dose of dexamethasone 8 mg IV given prior to starting the oxaliplatin on day 1. The primary endpoint was the percentage of subjects achieving complete response (CR; no vomiting/retching or use of rescue medication) during 120 h after initiation of chemotherapy in cycle 1.ResultsNo difference in the rate of CR was noted in the casopitant group compared to the placebo group for the overall (placebo 85%, casopitant 86%, p = 0.7273), acute (placebo 96%, casopitant 97%), or delayed phases (placebo 85%, casopitant 86%). The average area under curve (0–∞) of casopitant after a single 90-mg IV dose was 8,390 ng h/mL. At 24 h after casopitant 90-mg IV dosing, the plasma casopitant concentration was 24% lower than the values noted in prior studies with 150 mg oral administration, and the plasma exposure of the major metabolite (GSK525060) was 18% lower.ConclusionsAddition of single-dose casopitant 90 mg IV did not improve the control of CINV at any time during 120 h following initiation of oxaliplatin-based MEC. Excellent control of CINV was achieved in this study population with the combination of ondansetron and dexamethasone alone. More... »

PAGES

1471-1478

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00520-011-1235-4

DOI

http://dx.doi.org/10.1007/s00520-011-1235-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1007582767

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21822913


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33 schema:description PurposeThe primary objective was to determine if a single dose of casopitant 90 mg added to ondansetron and dexamethasone would improve the control of chemotherapy-induced nausea and vomiting (CINV) over 0–120 h following initiation of oxaliplatin-based moderately emetic chemotherapy (MEC) compared to ondansetron and dexamethasone alone.MethodsPatients with colorectal cancer received either casopitant or placebo intravenously (IV) added to ondansetron 8 mg bid oral on study days 1 to 3 and one dose of dexamethasone 8 mg IV given prior to starting the oxaliplatin on day 1. The primary endpoint was the percentage of subjects achieving complete response (CR; no vomiting/retching or use of rescue medication) during 120 h after initiation of chemotherapy in cycle 1.ResultsNo difference in the rate of CR was noted in the casopitant group compared to the placebo group for the overall (placebo 85%, casopitant 86%, p = 0.7273), acute (placebo 96%, casopitant 97%), or delayed phases (placebo 85%, casopitant 86%). The average area under curve (0–∞) of casopitant after a single 90-mg IV dose was 8,390 ng h/mL. At 24 h after casopitant 90-mg IV dosing, the plasma casopitant concentration was 24% lower than the values noted in prior studies with 150 mg oral administration, and the plasma exposure of the major metabolite (GSK525060) was 18% lower.ConclusionsAddition of single-dose casopitant 90 mg IV did not improve the control of CINV at any time during 120 h following initiation of oxaliplatin-based MEC. Excellent control of CINV was achieved in this study population with the combination of ondansetron and dexamethasone alone.
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41 ConclusionsAddition
42 Cr
43 MEC
44 MethodsPatients
45 Single-dose intravenous casopitant
46 administration
47 area
48 arm
49 average area
50 cancer
51 casopitant
52 casopitant 90
53 casopitant concentration
54 casopitant group
55 chemotherapy
56 chemotherapy-induced nausea
57 colorectal cancer
58 combination
59 combination of ondansetron
60 complete response
61 concentration
62 control
63 control of CINV
64 curve (0–∞) of casopitant
65 curves
66 days
67 dexamethasone 8
68 differences
69 dose
70 dosing
71 emetic chemotherapy
72 endpoint
73 excellent control
74 exposure
75 group
76 group study
77 initiation
78 initiation of chemotherapy
79 intravenous casopitant
80 major metabolite
81 metabolites
82 multicenter
83 nausea
84 objective
85 ondansetron
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87 oral administration
88 oxaliplatin
89 oxaliplatin-based MEC
90 oxaliplatin-induced nausea
91 parallel-group study
92 percentage
93 percentage of subjects
94 phase
95 placebo
96 placebo group
97 plasma casopitant concentration
98 plasma exposure
99 population
100 prevention
101 primary endpoint
102 primary objective
103 prior studies
104 rate
105 rate of CR
106 response
107 single dose
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