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Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer

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ClinicalTrials.gov Identifier: NCT00690924
Recruitment Status : Completed
First Posted : June 5, 2008
Results First Posted : October 11, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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: Prevention
Conditions Lung Cancer
Precancerous Condition
Tobacco Use Disorder
Interventions Drug: calcitriol
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Calcitriol
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calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Calcitriol
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calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study

Overall Number of Baseline Participants 16
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All treated and eligible patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
12
  75.0%
>=65 years
4
  25.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
60.1  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 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
16
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks
Hide Description

Number of participants with Adverse Events, Grade II lasting more than two weeks or Grade III or higher, graded according to CTEP Version 4 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting.

CTEP Version 4 of the CTCAE is identified and located at:

http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.

Time Frame 3 months
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Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Calcitriol
Hide Arm/Group Description:

calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: participants
II 1
III 0
IV 0
V 0
Time Frame 4 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Calcitriol
Hide Arm/Group Description

calcitriol: Oral

laboratory biomarker analysis: Correlative Study

pharmacological study: Correlative Study

All-Cause Mortality
Calcitriol
Affected / at Risk (%)
Total   0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Calcitriol
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Calcitriol
Affected / at Risk (%) # Events
Total   13/16 (81.25%)    
Blood and lymphatic system disorders   
Anaemia   1/16 (6.25%)  1
Cardiac disorders   
Arrhythmia   1/16 (6.25%)  1
Palpitations   1/16 (6.25%)  1
Eye disorders   
Eyelid irritation   1/16 (6.25%)  1
Gastrointestinal disorders   
Abdominal pain   1/16 (6.25%)  5
Constipation   2/16 (12.50%)  2
Dry mouth   1/16 (6.25%)  1
Nausea   1/16 (6.25%)  1
Vomiting   1/16 (6.25%)  1
General disorders   
Chills   1/16 (6.25%)  1
Facial pain   1/16 (6.25%)  1
Fatigue   2/16 (12.50%)  2
Malaise   1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Tooth fracture   1/16 (6.25%)  1
Investigations   
Aspartate aminotransferase increased   4/16 (25.00%)  5
Blood alkaline phosphatase increased   2/16 (12.50%)  2
Calcium ionised increased   2/16 (12.50%)  2
Metabolism and nutrition disorders   
Dehydration   1/16 (6.25%)  1
Hypercalcaemia   7/16 (43.75%)  13
Hyperglycaemia   4/16 (25.00%)  7
Hyperkalaemia   2/16 (12.50%)  3
Hypernatraemia   2/16 (12.50%)  2
Hypoglycaemia   4/16 (25.00%)  6
Hyponatraemia   4/16 (25.00%)  4
Musculoskeletal and connective tissue disorders   
Musculoskeletal chest pain   1/16 (6.25%)  1
Nervous system disorders   
Dizziness   1/16 (6.25%)  5
Headache   2/16 (12.50%)  3
Respiratory, thoracic and mediastinal disorders   
Cough   1/16 (6.25%)  1
Dysphonia   1/16 (6.25%)  1
Dyspnoea   2/16 (12.50%)  2
Epistaxis   1/16 (6.25%)  1
Nasal congestion   1/16 (6.25%)  1
Oropharyngeal pain   1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Hyperhidrosis   1/16 (6.25%)  1
Vascular disorders   
Hot flush   1/16 (6.25%)  1
Hypotension   1/16 (6.25%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00690924     History of Changes
Obsolete Identifiers: NCT01896804
Other Study ID Numbers: CDR0000596506
P30CA016056 ( U.S. NIH Grant/Contract )
I 90206
First Submitted: June 4, 2008
First Posted: June 5, 2008
Results First Submitted: July 13, 2017
Results First Posted: October 11, 2017
Last Update Posted: June 4, 2018