Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
|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: NCT00690924|
Recruitment Status : Active, not recruiting
First Posted : June 5, 2008
Results First Posted : October 11, 2017
Last Update Posted : January 8, 2018
RATIONALE: Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the lungs.
PURPOSE: This clinical trial is studying the side effects and best dose of calcitriol in preventing lung cancer in current smokers and former smokers at high risk of lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Precancerous Condition Tobacco Use Disorder||Drug: calcitriol Other: laboratory biomarker analysis Other: pharmacological study||Not Applicable|
- To establish the safety of calcitriol in patients at high risk of lung cancer.
- To determine the dose-limiting toxicities of calcitriol in these patients.
OUTLINE: Patients receive oral calcitriol on day 1. Courses repeat every 2 weeks for 3 months in absence of unacceptable toxicity.
Patients undergo blood collection periodically for pharmacokinetic and molecular analysis.
After completion of study therapy, patients are followed periodically.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer|
|Actual Study Start Date :||July 17, 2008|
|Actual Primary Completion Date :||March 7, 2017|
|Estimated Study Completion Date :||March 7, 2018|
OralOther: laboratory biomarker analysis
Correlative StudyOther: pharmacological study
- Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks [ Time Frame: 3 months ]
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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690924
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Mary Reid, PhD||Roswell Park Cancer Institute|