Originally published as JCO Early Release 10.1200/JCO.2008.20.6995 on May 18 2009

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Phase II Trial of Ixabepilone As Second-Line Treatment in Advanced Endometrial Cancer: Gynecologic Oncology Group Trial 129-P

From the Program in Women's Oncology of Women and Infants' Hospital, Departments of Obstetrics/Gynecology and Medicine, Warren Alpert Medical School of Brown University, Providence, RI; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Division of Gynecologic Oncology, University of Oklahoma HSC, Oklahoma City, OK; Department of Obstetrics/Gynecology, Adventist Hinsdale Hospital, Hinsdale, IL; and Department of Obstetrics and Gynecology, University of Alabama School of Medicine, Birmingham, AL.

Corresponding author: Don S. Dizon, MD, Program in Women's Oncology of Women and Infants, Hospital/Warren Alpert Medical School of Brown University, 101 Dudley St, Providence, RI 92905; e-mail: ddizon{at}wihri.org.

Purpose A phase II study was conducted to determine the response rate of ixabepilone (BMS-247550, National Cancer Institute (NCI)–supplied agent investigational new drug No. 59,699) in patients with persistent or recurrent endometrial cancer who have progressed despite standard therapy.

Patients and Methods Eligible patients had recurrent or persistent endometrial cancer and measurable disease. One prior chemotherapeutic regimen, which could have included either paclitaxel or docetaxel, was allowed. Patients received ixabepilone 40 mg/m² as a 3-hour infusion on day 1 of a 21-day cycle. Treatment was continued until disease progression or until unacceptable toxicity occurred.

Results Fifty-two patients were entered on the study, and 50 of these were eligible. The median age was 64 years (range, 40 to 83 years). Prior treatment included radiation in 21 patients (42%) and hormonal therapy in eight patients (16%). All patients had prior chemotherapy, and 47 (94%) received prior paclitaxel therapy. The overall response rate was 12%; one patient achieved a complete remission (2%), and five achieved partial remission (10%). Stable disease for at least 8 weeks was noted in 30 patients (60%). The median progression-free survival (PFS) was 2.9 months, and the 6-month PFS was 20%. Major grade 3 toxicities were neutropenia (52%), leukopenia (48%), gastrointestinal (24%), neurologic (18%), constitutional (20%), infection (16%), and anemia (14%).

Conclusion In a cohort of women with advanced or recurrent endometrial cancer who were previously treated with paclitaxel, ixabepilone showed modest activity of limited duration as a second-line agent.

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

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

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