Docetaxel or Cabazitaxel with Clarithromycin in Treating Patients with Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria

• 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 Prostate Cancer Working Group 2 (PCWG2)
• 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
• Radiographic progressive disease, irrespective of PSA changes, after receiving at least 4 cycles of docetaxel or cabazitaxel
• Bone disease documented by either: a positive bone scan, computed tomography (CT) scan, or magnetic resonance imaging (MRI); or biopsy proven bony metastases
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL
• Total bilirubin within normal institutional limits
• Docetaxel: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x upper limit of normal (ULN) (or =< 1.5 x ULN in conjunction with alkaline phosphatase (alk phos) > 2.5 x ULN
• Cabazitaxel: AST =< 1.5 x ULN
• Docetaxel: Creatinine clearance no minimum
• Cabazitaxel: Creatinine clearance >= 30 mL/min/1.73 m^2
• 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
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Patients who have residual toxicities > grade 2 attributed to taxane therapy, except for neuropathy, who are excluded if > grade 1
• Patients who are receiving any other investigational agents or have within the last 28 days
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to clarithromycin or taxanes
• Patients receiving any medications or substances that are inhibitors or inducers of CYP3A4 are ineligible; the subject requires concomitant treatment with the following inhibitors of CYP3A4: * Antibiotics: clarithromycin, erythromycin, telithromycin, troleandomycin; specifically, clarithryomycin is permitted for patients considered for this trial * Antifungals: itraconzaole, ketoconazole, voriconazole, fluconazole, posaconazole * Antidepressants: nefazodone * Antidiuretic: conivaptan * Antiretrovirals: delaviridine or protease inhibitors (ritonavir, indinavir, lopinavir/ritonavir, saquinavir, nelfinavir) or cobicistat-boosted antiretrovirals * Gastrointestinal (GI): cimetidine, aprepitant * Hepatitis C: boceprevir, telaprevir * Miscellaneous: Seville oranges, grapefruit, or grapefruit juice and/or pummelos, star fruit, exotic citrus fruits, or grapefruit hybrids)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Received more than 10 cycles of docetaxel (for docetaxel cohort only) or 6 of cabazitaxel (for cabazitaxel cohort only)
• Last docetaxel or cabazitaxel dose > 6 weeks prior to enrollment
• Patients with a documented history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes, or taking drugs that are known to prolong the QT