Neoadjuvant Weekly Ixabepilone for High Risk, Clinically Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ixabepilone; Prostatectomy
Intervention description: 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**
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: localized; high risk; prostate cancer; neoadjuvant treatment

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)
    

Eligibility 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