Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse And/Or Refractory Stage III Or IV Ovarian Epithelial Cancer, Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy
- Determine the antitumor activity of ixabepilone, in terms of clinical response and
progression-free survival, in patients with relapsed and/or refractory stage III or IV
ovarian epithelial or primary peritoneal cancer.
- Determine the nature and degree of toxicity of this drug in these patients.
- Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian
cancer cells with quality of response (i.e., at least partial response vs no response).
- Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms
with parent drug kinetic parameters, toxicity, and efficacy of this drug in these
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats
every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12
Masking: Open Label, Primary Purpose: Treatment
Incidence of clinical remission
Gary L. Goldberg, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Federal Government
|Albert Einstein Cancer Center at Albert Einstein College of Medicine||Bronx, New York 10461|