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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Pilot Study of Calcitriol in Smokers or Former Smokers With Squamous Metaplasia or Squamous Dysplasia of the Lungs

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Biomarker/Laboratory analysis, Prevention	Active	40 to 79	NCI	RPCI-I-90206 I 90205, NCT00690924

Trial Description

Purpose:

Calcitriol may prevent lung cancer in patients with metaplasia or dysplasia of the lungs.

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.

Eligibility:

Eligibility criteria include the following:

• 40-79 years old
• Metaplasia or dysplasia of the lungs diagnosed by bronchoscopy
• No current lung cancer or head and neck cancer
• No kidney stones
• At least 2 months since calcium supplements
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive calcitriol by mouth every 2 weeks for up to 3 months.

Patients will undergo blood collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated periodically.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Alex Adjei, MD, PhD, Principal investigator		Ph: 507-538-0268; 800-685-6825 Email: alex.adjei@roswellpark.org

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Alex Adjei, MD, PhD	Ph:  716-845-4101
			Email: alex.adjei@roswellpark.org

Registry Information
Official Title		A Pilot Study of Oral Calcitriol in Patients at High Risk for Lung Cancer
Trial Start Date		2008-07-17
Trial Completion Date		2010-12-19 (estimated)
Registered in ClinicalTrials.gov		NCT00690924
Date Submitted to PDQ		2008-05-16
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA112238, CA16056

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