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Oral Calcitriol With Ketoconazole in CRPC

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ClinicalTrials.gov Identifier: NCT03261336
Recruitment Status : Terminated (can not meet enrollment)
First Posted : August 25, 2017
Results First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Donald Trump, MD, Inova Health Care Services

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Castration-resistant Prostate Cancer
Intervention Drug: Calcitriol, Ketoconazole, Hydrocortisone
Enrollment 1
Recruitment Details Study was closed at site in 2018 due to enrollment challenges. Only 1 patient was enrolled to trial. No evaluable results.
Pre-assignment Details  
Arm/Group Title Calcitriol, Ketoconazole, Hydrocortisone
Hide Arm/Group Description

Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Calcitriol, Ketoconazole, Hydrocortisone
Hide Arm/Group Description

Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
78
(78 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title PSA Response Rate
Hide Description Assessment of PSA every 4 weeks
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient enrolled to study and was discontinued early due to AE.
Arm/Group Title Calcitriol, Ketoconazole, Hydrocortisone
Hide Arm/Group Description:

Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Tumor Response
Hide Description Objective tumor response among patients with measurable disease using modified RECIST1.1
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only one patient was enrolled and was discontinued due to AE.
Arm/Group Title Calcitriol, Ketoconazole, Hydrocortisone
Hide Arm/Group Description:

Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Toxicity and Tolerability of Experimental Arm
Hide Description Descriptive analysis of observed toxicity and patient reports of tolerating experimental treatment
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patient developed hypercalcemia and was discontinued from study. AE is known, not unexpected.
Arm/Group Title Calcitriol, Ketoconazole, Hydrocortisone
Hide Arm/Group Description:

Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

Overall Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame AE data was collected on a single patient during one month in 2017.
Adverse Event Reporting Description Definition consistent with clinicaltrials.gov
 
Arm/Group Title Calcitriol, Ketoconazole, Hydrocortisone
Hide Arm/Group Description

Patients receive calcitriol (10mcg QD X3 weekly) in addition to ketoconazole (400mg QD) and hydrocortisone (20mg AM, 10 mg PM).

Calcitriol, Ketoconazole, Hydrocortisone: Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol

All-Cause Mortality
Calcitriol, Ketoconazole, Hydrocortisone
Affected / at Risk (%)
Total   0/1 (0.00%)    
Hide Serious Adverse Events
Calcitriol, Ketoconazole, Hydrocortisone
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Blood and lymphatic system disorders   
hypercalcemia *  1/1 (100.00%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calcitriol, Ketoconazole, Hydrocortisone
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Study was closed due to inability to accrue. One patient was entered on study and did develop hypercalcemia which led to treatment discontinuation. Insufficient time on study to evaluate response.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Van Bebber, Sr. Director Clinical Trials
Organization: Inova Schar Cancer Institute
Phone: 5714720213
EMail: Stephanie.VanBebber@inova.org
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).
Layout table for additonal information
Responsible Party: Donald Trump, MD, Inova Health Care Services
ClinicalTrials.gov Identifier: NCT03261336    
Other Study ID Numbers: 16-2200
First Submitted: July 12, 2017
First Posted: August 25, 2017
Results First Submitted: January 19, 2021
Results First Posted: February 8, 2021
Last Update Posted: February 8, 2021