Originally published as JCO Early Release 10.1200/JCO.2009.24.1455 on November 16 2009

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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

From the University of Iowa Hospitals and Clinics, lowa City, IA; Gynecologic Oncology Group, Roswell Park Cancer Institute, Buffalo, NY; Wayne State University (Affiliate of Columbus Cancer Council/Ohio State), Detroit, MI; University of Chicago Medical Center, Chicago, IL; University of California Irvine, Chao Family Comprehensive Cancer Center, Orange, CA; University of Massachusetts Memorial Medical Center, Worcester, MA; Indiana University Medical Center, Indianapolis, IN; University of New Mexico, Albuquerque, NM; and University of Cincinnati, Cincinnati, OH.

Corresponding author: Koen De Geest, MD, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Iowa Hospitals and Clinics, 200 Hawkins Dr, Suite 4630 JCP, Iowa City, IA 52242; e-mail: koen-degeest{at}uiowa.edu.

Purpose Ixabepilone (BMS-247550) is a microtubule-stabilizing epothilone B analog with activity in taxane-resistant metastatic breast cancer. The Gynecologic Oncology Group conducted a phase II evaluation of the efficacy and safety of ixabepilone in patients with recurrent or persistent platinum- and taxane-resistant primary ovarian or peritoneal carcinoma.

Patients and Methods Patients with measurable platinum- and taxane-resistant ovarian or peritoneal carcinoma, defined as progression during or within 6 months of one prior course of treatment with each agent, received intravenous ixabepilone 20 mg/m² administered over 1 hour on days 1, 8, and 15 of a 28-day cycle.

Results Of 51 patients entered, 49 were eligible. The objective response rate was 14.3% (95% CI, 5.9% to 27.2%), with three complete and four partial responses. Twenty patients (40.8%) had stable disease, whereas sixteen (32.7%) had increasing disease. The median time to progression was 4.4 months (95% CI, 0.8 to 32.6+ months); median survival was 14.8 months (95% CI, 0.8 to 50.0) months. Patients received a median of two treatment cycles (range, 1 to 29 cycles), and 18.4% of patients received six cycles. Adverse effects included peripheral grade 2 (28.5%) and grade 3 (6.1%) neuropathy, grades 3 to 4 neutropenia (20.4%), grade 3 fatigue (14.3%), grade 3 nausea/emesis (22%), grade 3 diarrhea (10%), and grade 3 mucositis (4%).

Conclusion Ixabepilone 20 mg/m² over 1 hour on days 1, 8, and 15 of a 28-day cycle demonstrates antitumor activity and acceptable safety in patients with platinum- and taxane-resistant recurrent or persistent ovarian or primary peritoneal carcinoma.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (Grant No. CA 27469) and the Gynecologic Oncology Group Statistical and Data Center (Grant No. CA 37517).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00025155 [ClinicalTrials.gov] .

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