A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer

Trial ID #	NCT00025155; GOG-126M
Phase	II
Drug Class	Chemotherapy
Drug Name	Ixabepilone
Alternate Drug Names	Ixempra, Epothilone-B, epothilone B lactam, BMS-247550, Azaepothilone B
Drugs in Trial	Ixabepilone
Eligible Participant	Platinum resistant or refractory ovarian cancer (one prior therapy if first-line carboplatin+paclitaxel, if not 2 prior)
Patients Enrolled	49
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 14.3% (3CR, 4PR, n=49) DCR: 55.1% (3CR, 4PR, 20SD, n=49) PFS: 4.4 months OS: 14.8 months
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: neutropenia (20.4%), gastrointestinal (20%), leukopenia (14%), fatigue (14%)
Conclusion	Weekly ixabepilone has antitumor activity and acceptable toxicity
Reference	De Geest K et al. Phase II clinical trial of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant ovarian or primary peritoneal cancer: a gynecologic oncology group study. J Clin Oncol (2010) 28(1):149-53 https://www.ncbi.nlm.nih.gov/pubmed/19917861