Cohorts of Docetaxel or Cabazitaxel in Combination With the Potent CYP3A4 Inhibitor, Clarithromycin

Inclusion Criteria

• •1. Men with metastatic castrate-resistant prostate cancer (prostate cancer progressing despite castrate levels of testosterone \<50 ng/dL), using standard measures of progression defined by PCWG2
• •2. Have received at least 4 cycles of docetaxel or cabazitaxel, and less than ten, with two consecutive rising PSA values, checked at least 7 days apart. No PSA decline in last 42 day
• •3. Bone disease documented by either: a positive bone scan, CT scan, or MRI; or biopsy-proven bony metastases
• •4. Age ≥18 years
• •5. ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• •6. Have normal organ and marrow function defined as:
• •* absolute neutrophil count ≥1,500/mcL
• •* platelets ≥100,000/mcL
• •* total bilirubin (within normal institutional limits)
• •* AST/ALT ≤ 2.5 × ULN (or ≤ 1.5 x ULN in conjunction with alk phos \>2.5 x ULN for Docetaxel
• •* AST ≤ 1.5 x ULN for Cabazitaxel
• •* creatinine clearance-no minimum for Docetaxel
• •* creatinine clearance- ≥ 30 mL/min/1.73 m2 for Cabazitaxel
• •7. No evidence of clinical progression, in the form of increased lesions on cross-sectional imaging, or new cancer-attributable symptoms or worsening of existing symptoms
• •8. Ability to understand and the willingness to sign a written informed consent document