Fallopian Tube Cancer Clinical Trial
Official title:
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
This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women with advanced ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer or metastatic breast cancer. Drugs used in chemotherapy, such as ixabepilone and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PRIMARY OBJECTIVES:
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
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