Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
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.
|Lung Cancer Precancerous Condition Tobacco Use Disorder||Drug: calcitriol Other: laboratory biomarker analysis Other: pharmacological study|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
|Official Title:||A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer|
- Grade III-IV toxicities or any grade II toxicities lasting more than 2 weeks [ Time Frame: 3 months ]
|Actual Study Start Date:||July 17, 2008|
|Estimated Study Completion Date:||March 7, 2018|
|Primary Completion Date:||March 7, 2017 (Final data collection date for primary outcome measure)|
OralOther: laboratory biomarker analysis
Correlative StudyOther: pharmacological study
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690924
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Samjot Dhillon, MD||Roswell Park Cancer Institute|