Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent platinum-sensitive ovarian cancer
| Autor: | J Burke, Claire F. Verschraegen, P Celano, Y. Wang, T Schmelter, S McMeekin, M Giurescu, Prafull Ghatage, Steven C. Plaxe, C Stredder, R Patel |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Oncology
Adult Cancer Research medicine.medical_specialty endocrine system diseases Nausea medicine.medical_treatment Carboplatin chemistry.chemical_compound Recurrence Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Benzothiazoles Adverse effect sagopilone Aged Ovarian Neoplasms Chemotherapy business.industry Middle Aged medicine.disease Surgery Clinical trial ovarian cancer Tolerability chemistry Response Evaluation Criteria in Solid Tumors Epothilones Clinical Study Female medicine.symptom Ovarian cancer business |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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