A Phase I/II Study of BMS-247550 and Pegylated Liposomal Doxorubicin (Doxil®) in Patients With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Who Have Been Previously Treated With a Platinum and a Taxane
I. To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when
combined with pegylated doxorubicin hydrochloride (HCl) liposome (pegylated liposomal
doxorubicin hydrochloride) in women with previously treated advanced ovarian epithelial,
primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer.
II. To determine the safety profile of this regimen in these patients. III. To determine the
clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced
ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer.
OUTLINE: This is a phase I, multicenter, open-label, dose-escalation study of ixabepilone
followed by a phase II study.
Patients receive ixabepilone intravenously (IV) over 3 hours and pegylated liposomal
doxorubicin hydrochloride IV over 30-60 minutes on day 1. Courses repeat every 21-28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for up to 2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of ixabepilone, determined according to incidence of dose-limiting toxicity (DLT), graded using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4.0 (Phase I)
Montefiore Medical Center
United States: Food and Drug Administration
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