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Oral Calcitriol With Ketoconazole in CRPC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03261336
Recruitment Status : Terminated (can not meet enrollment)
First Posted : August 25, 2017
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Donald Trump, MD, Inova Health Care Services

No Study Results Posted on ClinicalTrials.gov for this Study
  Recruitment Status : Terminated
  Actual Primary Completion Date : February 28, 2018
  Actual Study Completion Date : February 28, 2018
Publications:
McElwain MC, Dettlebach MA, Modzelewski RA, et al. Antiproliferative effects in vitro and in vivo of 1,25-dihydroxyvitamin D3 and a vitamin D3 analog in a squamous cell carcinoma model system Mol Cell Diff 3 (1) 31 (1995).
Modzelewski RA. Apoptotic effects of paclitaxel and calcitriol in rat dunning MLL and human PC-3 prostate tumor cells in vitro. Proc Amer Assoc Cancer Res 40 580, 1999.
McGuire TF, Trump DL and Johnson CS. 1,25-dihydroxyvitamin D3 induces cytosolic accumulation of MEKK-1 before onset of apoptosis in a p38 MAPK-regulated manner. Proc. Amer. Assoc. Cancer Res. 2159, 435 (2002).
Johnson CS, Egorin MJ, Zuhowski R, 35 al. Effects of high dose calcitriol (1,25 dihydroxyvitamin D3) on the pharmacokinetics of paclitaxel or carboplatin: results of two phase I studies Amer Soc Clin Oncol 19 210a (2000).
Muindi JR, Modzelewski RA, Peng Y, Hershberger PA, Trump DL and Johnson CS. Plasma 1, 25-dihydroxycholecalciferol pharmacokinetics in normal and tumor bearing mice. Oncology (in press).
Hershberger PA, Modzelewski RA, Rueger RM, Blum KE, Trump DL, and Johnson CS. Enhanced anti-tumor efficacy with dexamethasone/calcitriol/cisplatin therapy: role of P21WAF1. Proc. Amer. Assoc. Cancer Res. 41, 15 (2000).
Yu WD, Rueger RM, Fuller RW, Johnson CS, and Trump DL. 1,25-dihydroxycholecalciferol (calcitriol) enhancement of chemotherapeutic efficacy: synergistic effects by median dose effect. Proc. Amer. Assoc. Cancer Res. 42, 84 (2001).
Trump DL, Serafine S, Brufsky J, et al. High dose calcitriol (1,25(OH)2 vitamin D3) + dexamethasone in androgen independent prostate cancer (AIPC). Amer Soc Clin Oncol 19 337a (2000).
Haynes RC. Agents affecting calcification: calcium, parathyroid hormone, calcitonin, vitamin D, and other compounds. The Pharmacological Basis of Therapeutics. Gilman AG, Rall TW, Nies AS, Taylor P (eds). New York Pergamon Press 1496 (1990).
Small EJ, Marshall ME, Reyno L, et al. Superiority of suramin plus hydrocortisone over placebo plus hydrocortisone: results of a multicenter, double-blind, phase II study in patients with hormone refractory prostate cancer. J Clin Oncol 17 308 (1998).
Davies M. High-dose vitamin D therapy: Indications, benefits and hazards. IN: Elevated Dosages of vitamins. P Walter, G Brubacher, H Stahelin (eds) Hans Humber, Lewistown, NY 81 (1989).
Beer TM, Eilers KM, Garzotto M, et al. Androgen-independent prostate Cancer (AIPC) treatment with weekly high-dose calcitriol and docetaxel. Amer Soc Clin Oncol 21 177a (2002).