Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles.

Prostatectomy 2-8 weeks after completion(standard of care and not a part of study)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Collaborators: Rhode Island Hospital; The Miriam Hospital
• Treatments: Epothilones

Criteria

Inclusion Criteria:

• 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 required.)

• 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 disease.)

• 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 single lobe.

• 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

Exclusion Criteria:

• Active or uncontrolled infection.

• Patients must not have other coexistent medical condition that would preclude protocol therapy.

• Previous severe hypersensitivity reaction to a drug formulated in CremophoreL (polyoxyethylated castor oil).

• Grade 1 or greater neuropathy (motor or sensory) at study entry