Title

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

Authors

Koen De Geest, University of Iowa Hospitals and Clinics
John A. Blessing, Roswell Park Cancer Institute
Robert T. Morris, Wayne State University
S. Diane Yamada, University of Chicago Medical Center
Bradley J. Monk, University of California Irvine
Susan L. Zweizig, University of Massachusetts Medical SchoolFollow
Daniela Matei, Indiana University Medical Center
Carolyn Y. Muller, University of New Mexico
William E. Richards, University of Cincinnati

UMMS Affiliation

Department of Obstetrics and Gynecology

Publication Date

2010-01-01

Document Type

Article

Subjects

Adult; Aged; Aged, 80 and over; Bridged Compounds; Drug Resistance, Neoplasm; Epothilones; Female; Humans; Middle Aged; Neoplasm Recurrence, Local; Organoplatinum Compounds; Ovarian Neoplasms; Peritoneal Neoplasms; Taxoids; Tubulin Modulators

Disciplines

Female Urogenital Diseases and Pregnancy Complications | Maternal and Child Health | Neoplasms | Obstetrics and Gynecology | Women's Health

Abstract

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/m(2) 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 > or = 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/m(2) 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.

DOI of Published Version

10.1200/JCO.2009.24.1455

Source

J Clin Oncol. 2010 Jan 1;28(1):149-53. doi: 10.1200/JCO.2009.24.1455. Epub 2009 Nov 16. Link to article on publisher's site

Journal/Book/Conference Title

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Related Resources

Link to Article in PubMed

PubMed ID

19917861

Repository Citation

De Geest K, Blessing JA, Morris RT, Yamada S, Monk BJ, Zweizig SL, Matei D, Muller CY, Richards WE. (2010). 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. Obstetrics and Gynecology Publications. https://doi.org/10.1200/JCO.2009.24.1455. Retrieved from https://escholarship.umassmed.edu/obgyn_pp/122