BrUOG-PROS-221 Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer: A Phase II Study
- Histologic documentation of prostatic adenocarcinoma. Patients with small cell,
neuroendocrine or transitional cell carcinomas are not eligible.
- All eligible patients must have a known Gleason sum based on biopsy or TURP at the
time of registration.
- Clinically Localized Disease: Patients must have clinical stage T1-T3a and no
radiographic evidence of metastatic disease as demonstrated by:
- Either CT or MRI of the abdomen and pelvis, that demonstrate no nodes > 1 cm: or
endorectal MRI(If one or more lymph nodes(s) measures > 1 cm, a negative biopsy is
- Negative bone scan (with plain films and /or MRI and/or CT scan confirmation, if
necessary).(Positive PET and Prostascint scans are not considered proof of metastatic
- Patients must have high risk disease defined as either:
- Gleason Score 8-10
- PSA > 15 ng/ml
- Stage T3a
- Stage T2c and Gleason score of 7
- Stage T2b, Gleason score of 7, greater than 50% of the cores positive from a
- No prior treatment for prostate cancer including prior surgery (excluding TURP),
pelvic lymph node dissection, radiation therapy, chemotherapy or hormone therapy.
- Patient must be appropriate candidates for radical prostatectomy with an estimated
life expectancy > 10 years as determined by an urologist.
- ECOG PS 0-1
- Age > 18 years of age.
- Required initial laboratory values:
- ANC > 1500/ul
- Platelet count > 100,000/mm3
- Creatinine < 2.0 mg/dl
- Serum PSA < 100 ng/ml
- Bilirubin < upper institutional limit of normal (ULN)
- AST/ALT < 2.5 X ULN
- Active or uncontrolled infection.
- Patients must not have other coexistent medical condition that would preclude
- Previous severe hypersensitivity reaction to a drug formulated in CremophoreL
(polyoxyethylated castor oil).
- Grade 1 or greater neuropathy (motor or sensory) at study entry