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

Alternate Title

Phase I/II Study of Calcitriol, Cisplatin, and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Temporarily closed	Over 18	NCI	RPCI-I-83706 NCT00470431, I 83706

Trial Description

Purpose:

Calcitriol may help non-small cell lung cancer cells become more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving calcitriol together with combination chemotherapy may kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of calcitriol when given together with cisplatin and docetaxel and to see how well they work in treating patients with advanced non-small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No previous surgery to remove part or all of a kidney
• More than 4 weeks since chemotherapy
• 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 1-hour infusions of calcitriol and docetaxel and an infusion of cisplatin on day 1. Treatment may repeat every 3 weeks for up to four courses.

Patients will undergo blood sample collection before beginning treatment for laboratory studies. Some patients will also undergo blood sample collection twice on day 1.

After finishing treatment, patients will be evaluated for 1 month and periodically 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

Roswell Park Cancer Institute

Grace Dy, MD, Principal investigator		Ph: 507-538-1760; 800-685-6825

Registry Information
Official Title		A Phase I/II Clinical Trial of Intravenous (IV) Calcitriol With Fixed Dose of Cisplatin and Docetaxel in Advanced Non-Small Cell Lung Cancer
Trial Start Date		2007-01-18
Trial Completion Date		2011-10-05 (estimated)
Registered in ClinicalTrials.gov		NCT00470431
Date Submitted to PDQ		2007-04-06
Information Last Verified		2009-06-07
NCI Grant/Contract Number		CA16056

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