Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer
- Conditions
- Lung CancerPrecancerous ConditionTobacco Use Disorder
- Interventions
- Registration Number
- NCT00690924
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Calcitriol calcitriol - Calcitriol laboratory biomarker analysis - Calcitriol pharmacological study -
- Primary Outcome Measures
Name Time Method Grade III-IV Toxicities or Any Grade II Toxicities Lasting More Than 2 Weeks 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:
http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States