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.
Tobacco Use Disorder
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Primary Completion Date:||December 2013 (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.
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263-0001|
|Contact: AskRPCI 877-275-7724 AskRPCI@RoswellPark.org|
|Principal Investigator:||Alex A. Adjei, MD, PhD||Roswell Park Cancer Institute|