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
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