Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Drug: Ixabepilone
Procedure: Prostatectomy

Registration Number: NCT00828308

Lead Sponsor: Brown University

Brief 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)

Detailed Description: Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care).

This protocol evaluated weekly ixabepilone prior to robotic prostatectomy for patients with high risk localized prostate cancer. PSA response rate, tumor margin status and pathologic responses were assessed.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ixabepilone	Prostatectomy	Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion \\\this was standard of care and not a part of the study\\\
Ixabepilone	Ixabepilone	Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion \\\this was standard of care and not a part of the study\\\

Primary Outcome Measures

Name	Time	Method
Prostate-Specific Antigen (PSA) Response	after 12 weeks of ixabepilone	Decrease in PSA:number of participants with decreased serum PSA level after 12 weeks of ixabepilone

Secondary Outcome Measures