A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer
- Histologically-confirmed localized prostate cancer
- Predicted probability of recurrence >/= 30% as defined by the updated Kattan nomogram
- Pathologic material available for gene expression analysis including cancer present
in 2 or more cores and availability of unstained slides or formalin-fixed paraffin
embedded tissue blocks.
- No prior prostate cancer therapy (including hormonal, chemotherapy, radiation or
- Subjects must be considered as candidates for radical prostatectomy
- EGOG status
- Men of child-bearing potential are required to use an effective means of
- Required Initial Laboratory Values:
- ANC >/= 1500/uL
- Platelet Count >/= 100000/uL
- Creatinine Bilirubin AST < 2.5 X ULN
- ALT < 2.5 X ULN
- Hemoglobin >/= 9.0 g/dL
- A history of significant ventricular arrhythmias
- Neuropathy (> grade 1)
- Recent (within 6 months) myocardial infarction, congestive heart failure, transient
ischemic attack or stroke
- Active angina, including active stable and unstable angina
- Acute deep venous thrombosis and/or pulmonary embolism in the past 6 months
- Any prior hormonal therapy including the use of PC Spes or estrogen containing
- Other co-existing malignancies or malignancies diagnosed within the last 5 years,
with the exception of basal cell carcinoma.
- Patients with malignancy diagnosed more than 5 years ago and are disease free for at
least 5 years are not excluded.
- Recent (within 4 weeks) surgery or incomplete healing from surgery
- Known history of hypersensitivity reaction to a drug formulated in Cremophor EL
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of
- Active infection requiring antibiotic therapy, or serious intercurrent illness.
- Any other major illness that in the investigators judgment will substantially
increase the risk associated with the subject's participation in this study.
- Unwillingness or inability to comply with procedures required in this protocol.