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