A Phase II Clinical Trial Of BMS-247550 (NSC 710428), An Epothilone B Analog, In Patients With Breast Carcinoma
- Determine any antitumor activity of ixabepilone, in terms of objective response rate,
in patients with incurable, locally advanced or metastatic breast cancer.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane
therapy (yes vs no).
Patients (with or without prior taxane exposure) receive ixabepilone IV over 1 hour on days
1-5. An additional cohort of 37 patients who have received prior taxane therapy are then
accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose. For all
patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable
toxicity. Patients who receive more than 6 courses with satisfactory response may be treated
every 4-5 weeks.
Patients removed for unacceptable toxicty are followed periodically.
PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane
exposure) will be accrued for this study within 26 months.
Masking: Open Label, Primary Purpose: Treatment
Anti-tumor activity as measured by CT scans and bone scans at baseline and every other course
Sandra M. Swain, MD
National Cancer Institute (NCI)
United States: Federal Government
|Suburban Hospital||Bethesda, Maryland 20814|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|
|Oncology Care Associates||Bethesda, Maryland 20817|