NCT00690924

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

A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 40 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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.

Conditions

• Lung Cancer
• Precancerous Condition
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	calcitriol	Oral
OTHER	laboratory biomarker analysis	Correlative Study
OTHER	pharmacological study	Correlative Study

Timeline

• Start date: 2008-07-17
• Primary completion: 2017-03-07
• Completion: 2018-03-07
• First posted: 2008-06-05
• Last updated: 2018-06-04
• Results posted: 2017-10-11

Locations

1 site across 1 country: United States