PMID- 22108514
OWN - NLM
STAT- MEDLINE
DCOM- 20120214
LR  - 20240404
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Print)
IS  - 0007-0920 (Linking)
VI  - 106
IP  - 1
DP  - 2012 Jan 3
TI  - Phase I/II study of sagopilone (ZK-EPO) plus carboplatin in women with recurrent 
      platinum-sensitive ovarian cancer.
PG  - 70-6
LID - 10.1038/bjc.2011.499 [doi]
AB  - 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.
FAU - McMeekin, S
AU  - McMeekin S
AD  - University of Oklahoma Health Sciences Center, Department of Obstetrics and 
      Gynecology, 825 NE 10th Street, Oklahoma City, OK 73104, USA. 
      scott-mcmeekin@ouhsc.edu
FAU - Patel, R
AU  - Patel R
FAU - Verschraegen, C
AU  - Verschraegen C
FAU - Celano, P
AU  - Celano P
FAU - Burke, J 2nd
AU  - Burke J 2nd
FAU - Plaxe, S
AU  - Plaxe S
FAU - Ghatage, P
AU  - Ghatage P
FAU - Giurescu, M
AU  - Giurescu M
FAU - Stredder, C
AU  - Stredder C
FAU - Wang, Y
AU  - Wang Y
FAU - Schmelter, T
AU  - Schmelter T
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20111122
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
RN  - 0 (Benzothiazoles)
RN  - 0 (Epothilones)
RN  - BG3F62OND5 (Carboplatin)
RN  - KY72JU32FO (sagopilone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Benzothiazoles/administration & dosage
MH  - Carboplatin/administration & dosage
MH  - Epothilones/administration & dosage
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Ovarian Neoplasms/*drug therapy/pathology
MH  - Recurrence
PMC - PMC3251849
COIS- R Patel, C Verschraegen, P Celano, J Burke, S Plaxe, P Ghatage and Y Wang declare 
      no conflict of interest. M Giurescu (Senior Director), C Stredder (Global Study 
      Manager) and T Schmelter (Study Statistician) are all employees of Bayer 
      HealthCare Pharmaceuticals. S McMeekin received funding from Bayer HealthCare 
      Pharmaceuticals for trial enrollment and has participated in advisory boards for 
      Bayer HealthCare Pharmaceuticals.
EDAT- 2011/11/24 06:00
MHDA- 2012/02/15 06:00
PMCR- 2013/01/03
CRDT- 2011/11/24 06:00
PHST- 2011/11/24 06:00 [entrez]
PHST- 2011/11/24 06:00 [pubmed]
PHST- 2012/02/15 06:00 [medline]
PHST- 2013/01/03 00:00 [pmc-release]
AID - bjc2011499 [pii]
AID - 10.1038/bjc.2011.499 [doi]
PST - ppublish
SO  - Br J Cancer. 2012 Jan 3;106(1):70-6. doi: 10.1038/bjc.2011.499. Epub 2011 Nov 22.