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- Title
Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer.
- Authors
McMeekin, S; Patel, R; Verschraegen, C; Celano, P; Burke, J; Plaxe, S; Ghatage, P; Giurescu, M; Stredder, C; Wang, Y; Schmelter, T
- Abstract
Background:Sagopilone is the first fully synthetic epothilone in clinical development and has demonstrated promising preclinical activity. This phase I/II, prospective, open-label trial investigated the efficacy and safety of sagopilone plus carboplatin in patients with recurrent platinum-sensitive ovarian cancer (OC).Methods:In phase I (dose-escalation stage), patients with OC recurring at least 6 months after platinum-containing chemotherapy received 3-h infusions of sagopilone (initial dose of 12 mg m−2) followed by carboplatin every 3 weeks, for 2-6 treatment courses. Patients enrolled in phase II received 3-h infusions of 16 mg m−2 sagopilone. Efficacy was assessed using modified Response Evaluation Criteria in Solid Tumors (modRECIST) and Gynecologic Cancer InterGroup CA125 criteria. The safety and tolerability of sagopilone were also evaluated.Results:In all, 45 patients received sagopilone at 12 mg m−2 or 16 mg m−2. There were 29 confirmed tumour responses (21 modRECIST and 8 CA125) across both treatment groups, indicating that the primary objective of the study was reached. The main adverse events (AEs) reported were peripheral neuropathy (75.6%), fatigue (71.1%) and nausea (64.4%). Grade 3 AEs occurred in 35 patients (77.8%). No deaths related to the study drug were reported.Conclusion:Sagopilone in combination with carboplatin was effective and toxicities were manageable in patients with recurrent platinum-sensitive OC.
- Subjects
OVARIAN cancer; DIAGNOSIS of cancer in female reproductive organs; CANCER chemotherapy; DOSAGE forms of drugs; ADVERSE health care events; NEUROPATHY; FATIGUE (Physiology)
- Publication
British Journal of Cancer, 2012, Vol 106, Issue 1, p70
- ISSN
0007-0920
- Publication type
Article
- DOI
10.1038/bjc.2011.499