A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer - PubMed (original) (raw)
Clinical Trial
. 2011 Nov;22(11):2411-2416.
doi: 10.1093/annonc/mdq780. Epub 2011 Mar 3.
N Reed 2, G C Jayson 3, J A Ledermann 4, M Adams 5, T Perren 6, C Poole 7, M Lind 8, M Persic 9, S Essapen 10, M Gore 11, H Calvert 12, C Stredder 13, A Wagner 14, M Giurescu 14, S Kaye 11
Affiliations
- PMID: 21372124
- DOI: 10.1093/annonc/mdq780
Free article
Clinical Trial
A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer
G Rustin et al. Ann Oncol. 2011 Nov.
Free article
Abstract
Background: Sagopilone, the first fully synthetic epothilone, has shown promising preclinical activity in tumour models. This open-label randomised phase II study investigated two infusion schedules of sagopilone in women with ovarian cancer.
Patients and methods: Women with ovarian cancer recurring within 6 months of end of last platinum-containing treatment received sagopilone 16 mg/m(2) as a 3- or 0.5-h i.v. infusion every 21 days for up to 6 weeks.
Results: Sixty-three patients received sagopilone as a 3-h (n=38) or 0.5-h (n=25) infusion. There were nine confirmed tumour responses [by modified RECIST (n=8) and by Gynecologic Cancer Intergroup CA-125 criteria (n=1)] in 57 patients assessable for efficacy overall [three (13%) with 0.5-h and six (18%) with 3-h infusions]. The 0.5-h arm was closed when it failed to meet its target efficacy. Main drug-related adverse events were peripheral sensory neuropathy (73%; 16% grade 3), nausea (37%; 2% grade 3), fatigue (35%; 3% grade 3) and arthralgia (30%; 5% grade 3). Overall incidence of peripheral sensory neuropathy was similar in both treatment arms, with no grade 4 neuropathy events. No acute allergic infusion reactions were observed.
Conclusion: Sagopilone is effective, with balanced tolerability, in patients with recurrent platinum-resistant ovarian cancer.
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