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

Alternate Title

Phase II Randomized Chemoprevention Study of Iloprost in Patients at High Risk for Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active 18 and over NCI UCHSC-01279 NCT00084409

Special Category: SPORE trial

Trial Description

Purpose:

Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.

This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Smoked at least one pack a day for 20 years or 2 packs a day for 10 years
• More than 5 years since chemotherapy
• More than 5 years since radiation therapy to the chest
• More than 6 weeks since inhaled steroids
• 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 be randomly assigned to one of two groups. Patients in group one will receive iloprost by mouth twice a day for up to 6 months. Patients in group two will receive a placebo by mouth twice a day for up to 6 months. Patients will be evaluated at 1 month and once a year thereafter.

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

University of Colorado Cancer Center at UC Health Sciences Center

Robert Keith, MD, Principal investigator		Ph: 303-393-2869; 800-473-2288

U.S.A.
Colorado
	Aurora
	University of Colorado Cancer Center at UC Health Sciences Center
		Clinical Trials Office - University of Colorado Cancer Center	Ph:  720-848-0650
	Denver
	Veterans Affairs Medical Center - Denver
		Robert Keith, MD	Ph:  303-393-2869 888-336-8262
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
Minnesota
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Pennsylvania
	Pittsburgh
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;

Registry Information
Official Title		A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer
Trial Start Date		2001-11-01
Registered in ClinicalTrials.gov		NCT00084409
Date Submitted to PDQ		2003-10-20
Information Last Verified		2008-04-06
NCI Grant/Contract Number		CA46934, CA58187