Ovarian Cancer Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop
tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who
have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary
peritoneal cancer.
OBJECTIVES:
Primary
- 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.
Secondary
- 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
patients.
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
toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
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