Trial Outcomes & Findings for Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00524589)
NCT ID: NCT00524589
Last Updated: 2017-11-20
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2017-11-20
Participant Flow
Participant milestones
| Measure |
Dexamethasone and Calcitriol
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 Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Dexamethasone and Calcitriol
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 Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
16
|
Baseline Characteristics
Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Dexamethasone and Calcitriol
n=18 Participants
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
|
|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All treated and eligible patients
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.
Outcome measures
| Measure |
Dexamethasone and Calcitriol
n=18 Participants
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
|
|---|---|
|
Objective Response (Complete or Partial Response)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All treated and eligible patients
Number of patients with corrected serum calcium levels between 11 mg/dL and 12 mg/dL detected on 1 or more occasions.
Outcome measures
| Measure |
Dexamethasone and Calcitriol
n=18 Participants
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
|
|---|---|
|
Corrected Serum Calcium Expression
|
6 Participants
|
Adverse Events
Dexamethasone and Calcitriol
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone and Calcitriol
n=18 participants at risk
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
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
5.6%
1/18 • Number of events 2
|
|
Cardiac disorders
Arrhythmia
|
5.6%
1/18 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
5.6%
1/18 • Number of events 2
|
|
General disorders
Chest pain
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Heart rate irregular
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
2/18 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.6%
1/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18 • Number of events 4
|
Other adverse events
| Measure |
Dexamethasone and Calcitriol
n=18 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
44.4%
8/18 • Number of events 22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
2/18 • Number of events 4
|
|
Eye disorders
Vision blurred
|
5.6%
1/18 • Number of events 2
|
|
Eye disorders
Visual disturbance
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
3/18 • Number of events 8
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 2
|
|
General disorders
Asthenia
|
5.6%
1/18 • Number of events 2
|
|
General disorders
Chest pain
|
11.1%
2/18 • Number of events 4
|
|
General disorders
Fatigue
|
38.9%
7/18 • Number of events 18
|
|
General disorders
Oedema peripheral
|
11.1%
2/18 • Number of events 4
|
|
General disorders
Pain
|
5.6%
1/18 • Number of events 2
|
|
General disorders
Pyrexia
|
11.1%
2/18 • Number of events 4
|
|
Infections and infestations
Infection
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Blood albumin decreased
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
3/18 • Number of events 6
|
|
Investigations
Blood bilirubin increased
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Blood creatine increased
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Blood creatinine increased
|
22.2%
4/18 • Number of events 18
|
|
Investigations
Blood urea
|
5.6%
1/18 • Number of events 2
|
|
Investigations
Blood urea increased
|
16.7%
3/18 • Number of events 6
|
|
Investigations
Blood urine present
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
44.4%
8/18 • Number of events 44
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
44.4%
8/18 • Number of events 24
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
2/18 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
2/18 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.6%
1/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
6/18 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
4/18 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
5.6%
1/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
11.1%
2/18 • Number of events 4
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 2
|
|
Nervous system disorders
Sinus headache
|
5.6%
1/18 • Number of events 2
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
11.1%
2/18 • Number of events 4
|
|
Renal and urinary disorders
Haematuria
|
11.1%
2/18 • Number of events 6
|
|
Renal and urinary disorders
Micturition urgency
|
11.1%
2/18 • Number of events 6
|
|
Renal and urinary disorders
Urinary hesitation
|
5.6%
1/18 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
5.6%
1/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
2/18 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
5.6%
1/18 • Number of events 2
|
|
Surgical and medical procedures
Dermabrasion
|
5.6%
1/18 • Number of events 2
|
|
Vascular disorders
Flushing
|
22.2%
4/18 • Number of events 9
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 2
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place