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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 Azacitidine, Docetaxel, and Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Biomarker/Laboratory analysis, Natural history/Epidemiology, Treatment Active 18 and over Other, Pharmaceutical / Industry SCCC-2006080 SCCC 2006080, SCCC-EPROST-20061143, WIRB-20070344, PHARMION-SCCC-2006080, NCT00503984

Trial Description

Purpose:

Drugs used in chemotherapy, such as azacitidine 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 azacitidine and docetaxel together with prednisone may kill more tumor cells.

This phase I/II trial is studying the side effects and best dose of azacitidine and docetaxel when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Received at least 6 weeks of docetaxel
• No brain metastases or liver cancer
• More than 8 weeks since strontium 89 or samarium 153
• More than 4 weeks since chemotherapy, radiation therapy, or surgery
• 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 an infusion of azacitidine on days 1-5 and a 1-hour infusion of docetaxel on day 6. They will also receive prednisone by mouth once a day for 3 weeks. Treatment may repeat every 3 weeks for as long as benefit is shown.

Some patients may undergo blood sample collection for laboratory studies on days 1 and 6 of the first two courses.

Pain will be assessed every 3 weeks and at the end of treatment. After finishing treatment, pain will be assessed every 6 weeks for 6 months and every 3 months thereafter.

After finishing treatment, patients will be evaluated every 3 months for 6 months, every 6 months for 1 year, 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 Miami Sylvester Comprehensive Cancer Center - Miami

Rakesh Singal, MD, Protocol chair		Ph: 305-243-4909

U.S.A.
Florida
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com

Registry Information
Official Title		A Phase I/II Study of Azacitidine (Vidaza®), Docetaxel and Prednisone for Patients with Metastatic Hormone Refractory Prostate Cancer
Trial Start Date		2007-05-01
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00503984
Date Submitted to PDQ		2007-06-26
Information Last Verified		2008-12-08

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