A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer.

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.

• Authors: G Rustin, N Reed, G C Jayson, J A Ledermann, M Adams, T Perren, C Poole, M Lind, M Persic, S Essapen, M Gore, H Calvert, C Stredder, A Wagner, M Giurescu, S Kaye
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 22 Issue 11 Pg. 2411-2416 (Nov 2011) ISSN: 1569-8041 [Electronic] England
• PMID: 21372124 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Benzothiazoles
• Epothilones
• sagopilone

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (administration & dosage, adverse effects)
• Benzothiazoles (administration & dosage, adverse effects)
• Disease-Free Survival
• Drug Administration Schedule
• Drug Resistance, Neoplasm
• Epothilones (administration & dosage, adverse effects)
• Female
• Humans
• Infusions, Intravenous
• Middle Aged
• Ovarian Neoplasms (drug therapy)