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

Alternate Title

Phase I Study of Ketoconazole and Docetaxel in Patients With Metastatic Androgen-Independent Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	NCI-02-C-0149 NCT00039221

Trial Description

Purpose:

Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining ketoconazole with docetaxel may kill more tumor cells.

Phase I trial to study the effectiveness of combining ketoconazole with docetaxel in treating patients who have metastatic prostate cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases
• At least 4 weeks since flutamide
• At least 6 weeks since bicalutamide or nilutamide
• 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 a 1-hour infusion of docetaxel once a week for 3 weeks. They will also receive ketoconazole by mouth three times a day in weeks 3-4. Beginning with course two, patients will receive an infusion of docetaxel once a week for 3 weeks and ketoconazole by mouth once a day. Treatment may be repeated every 4 weeks for as long as benefit is shown. Patients will be evaluated once a month.

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

NCI - Center for Cancer Research

William Dahut, MD, Principal investigator		Ph: 301-435-8183 Email: dahutw@mail.nih.gov

Related Information

Web site for additional information

Registry Information
Official Title		A Phase I Trial Of High Dose Ketoconazole Plus Weekly Docetaxel In Metastatic Androgen Independent Prostate Cancer
Trial Start Date		2002-04-02
Trial Completion Date		2008-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00039221
Date Submitted to PDQ		2002-04-08
Information Last Verified		2009-06-14

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