A phase 2 study of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Canadian Urologic Oncology Group study P07a

Background: The purpose of this study was to determine the clinical activity of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel. Patients and methods: Eligible patients had progressive disease within 6 months of receiving docetaxel. Patupilone was administered 10 mg/m 2 i.v. every 3 weeks. The primary end point was the proportion of patients with a confirmed =50 prostate-specific antigen (PSA) decline. Results: Eighty-three patients were enrolled. At baseline, the median time to progression after prior docetaxel was 1.4 months (range 0-5.7). Gastrointestinal serious adverse events occurred in four of the six initial patients leading to a reduction of the starting dose of patupilone to 8 mg/m 2 for subsequent patients. Grade 3-4 toxicity at this dose included diarrhea (22 ), fatigue (21 ), and anorexia (10 ). One patient experienced grade 3-4 hematologic toxicity. A PSA decline of =50 occurred in 47 of patients. A partial measurable disease response occurred in 24 of assessable patients. A patient-reported pain response was observed in 59 of assessable patients. Median time to PSA progression was 6.1 months [95 confidence interval (CI) 4.7-8.0] and median overall survival was 11.3 months (95 CI 9.8-15.4). Conclusions: Patupilone at 8 mg/m 2 was tolerable, had antitumor activity, and was associated with symptomatic improvement in patients previously treated with docetaxel