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Vorinostat in advanced prostate cancer patients progressing on prior chemotherapy (National Cancer Institute Trial 6862)
Cancer, 09/01/09
Bradley D et al. – Vorinostat at 400 mg po qd was associated with significant toxicities, thus limiting efficacy assessment in this patient population.
Methods- Phase 2 trial
- 27 chemotherapy pre-treated patients with metastatic castration-resistant prostate cancer
- The median number of cycles was 2; no patients had > 5 mos
- SD was achieved in 2 patients
- No PSA levels decreased ≥ 50%
- 1 patient had a grade 4 AE; 44% of patients had grade 3 AEs (fatigue, nausea, anorexia, vomiting, diarrhea, and weight loss)
- Median TTP was 2.8 mos
- Median OS was 11.7 mos
- Median IL-6 levels were higher in patients d/c's for toxicity compared to patients with progression
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