Page 251 - Vitamin D and Cancer

238 C.M. Barnett and T.M. Beer

Efficacy results 1 of 17 patients had a PSA response 81% had PSA response. 8 of 15 responded in measurable disease. Median overall survival 19.5 months Improved survival with DN-101 (HR 0.67, p = 0.035), trend favoring DN-101 with respect to PSA response rates (overall 63% vs 52%, p = 0.07, within 6 months

Number of patients 17 37 250 (125 DN-101, 125 placebo) 24 37 19

Companion drugs Carboplatin AUC of 7 (6 in patients with prior radiation) every 28 days Docetaxel 36 mg/m 2 weekly for 6 consecutive weeks repeated every 8 weeks Docetaxel 36 mg/m 2 weekly for 3 consecutive weeks repeated every 4 weeks Estramustine 280 mg on days 1–5, and docetaxel 70 mg/ m 2 on day 2 Dexam

Phase II studies of high dose calcitriol combinations
Schedule of oral calcitriol 24 h prior to carboplatin every 4 weeks 24 h prior to each dose of docetaxel weekly 24 h prior to each dose of docetaxel weekly 24 h prior to each dose of docetaxel 3-weekly Daily for 3 days every 7 days/orally 24 h prior to each dose of mitoxantrone 3-weekly

Dose 0.5 mg/kg 0.5 mg/kg 45 mg (DN-101) 45 mg (DN-101) 8–12 mg 180 mg (DN-101)

Table 10.6 Investigator Beer (2004) [143] Beer (2003) [139] Beer (2007) [140] Tiffany (2005) [142] Trump (2006) [141] Chen (in press)