Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

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: NCT00524589
Recruitment Status : Terminated (closed due to futility)
First Posted : September 3, 2007
Results First Posted : March 10, 2014
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Interventions Dietary Supplement: calcitriol
Drug: dexamethasone
Genetic: protein expression analysis
Other: laboratory biomarker analysis
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dexamethasone and Calcitriol
Hide Arm/Group Description

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study

Period Title: Overall Study
Started 18
Completed 0
Not Completed 18
Reason Not Completed
Withdrawal by Subject             2
Disease Progression             16
Arm/Group Title Dexamethasone and Calcitriol
Hide Arm/Group Description

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
68.2  (11.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  38.9%
>=65 years
11
  61.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
1.Primary Outcome
Title Objective Response (Complete or Partial Response)
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Dexamethasone and Calcitriol
Hide Arm/Group Description:

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Corrected Serum Calcium Expression
Hide Description Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Dexamethasone and Calcitriol
Hide Arm/Group Description:

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
6
  33.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexamethasone and Calcitriol
Hide Arm/Group Description

Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.

calcitriol: IV

dexamethasone: Oral

protein expression analysis: Correlative Study

laboratory biomarker analysis: Correlative Study

All-Cause Mortality
Dexamethasone and Calcitriol
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dexamethasone and Calcitriol
Affected / at Risk (%) # Events
Total   4/18 (22.22%)    
Cardiac disorders   
Angina pectoris   1/18 (5.56%)  2
Arrhythmia   1/18 (5.56%)  2
Palpitations   1/18 (5.56%)  2
Sinus tachycardia   1/18 (5.56%)  2
General disorders   
Chest pain   1/18 (5.56%)  2
Investigations   
Heart rate irregular   1/18 (5.56%)  2
Metabolism and nutrition disorders   
Hypocalcaemia   2/18 (11.11%)  6
Hypophosphataemia   1/18 (5.56%)  2
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   2/18 (11.11%)  4
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexamethasone and Calcitriol
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   8/18 (44.44%)  22
Thrombocytopenia   2/18 (11.11%)  4
Eye disorders   
Vision blurred   1/18 (5.56%)  2
Visual disturbance   1/18 (5.56%)  2
Gastrointestinal disorders   
Abdominal pain upper   1/18 (5.56%)  2
Constipation   3/18 (16.67%)  6
Diarrhoea   3/18 (16.67%)  8
Dyspepsia   2/18 (11.11%)  4
Nausea   2/18 (11.11%)  4
Vomiting   1/18 (5.56%)  2
General disorders   
Asthenia   1/18 (5.56%)  2
Chest pain   2/18 (11.11%)  4
Fatigue   7/18 (38.89%)  18
Oedema peripheral   2/18 (11.11%)  4
Pain   1/18 (5.56%)  2
Pyrexia   2/18 (11.11%)  4
Infections and infestations   
Infection   1/18 (5.56%)  2
Investigations   
Aspartate aminotransferase increased   1/18 (5.56%)  2
Blood albumin decreased   1/18 (5.56%)  2
Blood alkaline phosphatase increased   3/18 (16.67%)  6
Blood bilirubin increased   1/18 (5.56%)  2
Blood creatine increased   1/18 (5.56%)  2
Blood creatinine increased   4/18 (22.22%)  18
Blood urea   1/18 (5.56%)  2
Blood urea increased   3/18 (16.67%)  6
Blood urine present   1/18 (5.56%)  2
Metabolism and nutrition disorders   
Anorexia   1/18 (5.56%)  2
Hypercalcaemia   8/18 (44.44%)  44
Hyperglycaemia   8/18 (44.44%)  24
Hypoalbuminaemia   2/18 (11.11%)  4
Hypocalcaemia   2/18 (11.11%)  4
Hypoglycaemia   1/18 (5.56%)  2
Hyponatraemia   1/18 (5.56%)  2
Hypophosphataemia   6/18 (33.33%)  12
Musculoskeletal and connective tissue disorders   
Arthralgia   2/18 (11.11%)  4
Back pain   4/18 (22.22%)  10
Groin pain   1/18 (5.56%)  2
Neck pain   1/18 (5.56%)  2
Pain in extremity   1/18 (5.56%)  2
Nervous system disorders   
Dizziness   2/18 (11.11%)  4
Headache   1/18 (5.56%)  2
Sinus headache   1/18 (5.56%)  2
Tremor   1/18 (5.56%)  2
Psychiatric disorders   
Insomnia   2/18 (11.11%)  4
Renal and urinary disorders   
Haematuria   2/18 (11.11%)  6
Micturition urgency   2/18 (11.11%)  6
Urinary hesitation   1/18 (5.56%)  2
Urinary retention   1/18 (5.56%)  2
Respiratory, thoracic and mediastinal disorders   
Cough   1/18 (5.56%)  2
Dyspnoea   2/18 (11.11%)  4
Nasal congestion   1/18 (5.56%)  2
Skin and subcutaneous tissue disorders   
Onychoclasis   1/18 (5.56%)  2
Surgical and medical procedures   
Dermabrasion   1/18 (5.56%)  2
Vascular disorders   
Flushing   4/18 (22.22%)  9
Hypertension   1/18 (5.56%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00524589     History of Changes
Other Study ID Numbers: CDR0000563197
RPCI I-65405 ( Other Identifier: Roswell Park Cancer Institute )
First Submitted: August 31, 2007
First Posted: September 3, 2007
Results First Submitted: January 27, 2014
Results First Posted: March 10, 2014
Last Update Posted: November 20, 2017