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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 Study of Docetaxel and Prednisolone With or Without Zoledronic Acid and/or Strontium Chloride Sr 89 in Patients With Hormone-Refractory Prostate Cancer Metastatic to Bone

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 and over	Other, Pharmaceutical / Industry	CRUK-TRAPEZE-2100 PR2100, EUDRACT-2004-002295-41, EU-20782, ISRCTN12808747, SANOFI-AVENTIS-CRUK-TRAPEZE-2100, NOVARTIS-CRUK-TRAPEZE-2100, NCT00554918

Trial Description

Purpose:

Drugs used in chemotherapy, such as docetaxel and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Zoledronic acid may help relieve some of the symptoms caused by bone metastases. Radioactive substances, such as strontium chloride Sr 89, may help relieve bone pain caused by prostate cancer. Giving docetaxel together with prednisolone with or without zoledronic acid and/or strontium chloride Sr 89 may kill more tumor cells.

This randomized phase II trial is studying the side effects and how well giving docetaxel together with prednisolone works with or without zoledronic acid and/or strontium chloride Sr 89 in treating patients with prostate cancer metastatic to bone that has not responded to hormone therapy.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Underwent previous surgery to remove both testicles or is receiving luteinizing hormone-releasing hormone agonist therapy
• Progressive disease
• No brain metastases or leptomeningeal metastases
• At least 4 weeks since flutamide, nilutamide, cyproterone acetate, or estramustine
• At least 6 weeks since bicalutamide
• No previous chemotherapy other than estramustine for this cancer
• 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 (have an equal chance of being placed) to one of four treatment groups.

Patients in group one will receive an infusion of docetaxel on day 1 and prednisolone by mouth once a day.

Patients in group two will receive an infusion of docetaxel on day 1, prednisolone by mouth once a day, and an infusion of zoledronic acid on day 1.

Patients in group three will receive an infusion of docetaxel on day 1, prednisolone by mouth once a day, and a single infusion of strontium chloride Sr 89 on day 7 of course two.

Patients in group four will receive an infusion of docetaxel on day 1, prednisolone by mouth once a day, an infusion of zoledronic acid on day 1, and a single infusion of strontium chloride Sr 89 on day 7 of course two.

Treatment with docetaxel, prednisolone, and zoledronic acid may repeat every 3 weeks for up to six courses. Strontium chloride Sr 89 will be given only once.

Patients will fill out quality-of-life questionnaires at the beginning of the study and every 3 months during follow-up. After finishing treatment, patients will be evaluated every 3 months.

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

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Nicholas James, MD, Protocol chair		Ph: 44-121-697-8314 Email: n.d.james@bham.ac.uk

United Kingdom
England
	Birmingham
	Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
		Nicholas James, MD	Ph:  44-121-697-8314
			Email: n.d.james@bham.ac.uk
	Cheltenham
	Gloucestershire Oncology Centre at Cheltenham General Hospital
		Contact Person	Ph:  44-8454-222-222
	Gloucester
	Gloucestershire Royal Hospital
		Contact Person	Ph:  44-1452-528-555
	Ipswich
	Ipswich Hospital
		Contact Person	Ph:  44-1473-712-233
	Maidstone
	Mid Kent Oncology Centre at Maidstone Hospital
		Contact Person	Ph:  44-1622-729-000
	Manchester
	Christie Hospital
		Contact Person	Ph:  44-845-226-3000
	Sutton
	Royal Marsden - Surrey
		Contact Person	Ph:  44-20-8642-6011
	Walsall
	Walsall Manor Hospital
		Contact Person	Ph:  44-1922-721-172
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Contact Person	Ph:  44-84-5456-6000
	Ayr
	Ayr Hospital
		Contact Person	Ph:  44-1292-610-555
	Edinburgh
	Edinburgh Cancer Centre at Western General Hospital
		Contact Person	Ph:  44-131-537-1000
	Glasgow
	Beatson West of Scotland Cancer Centre
		Contact Person	Ph:  44-141-211-2123
	Kilmarnock
	Crosshouse Hospital
		Contact Person	Ph:  44-1563-521-133
	Wishaw
	Wishaw General Hospital
		Contact Person	Ph:  44-169-836-1100
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Contact Person	Ph:  44-29-2031-6292
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Contact Person	Ph:  44-1745-583-910

Registry Information
Official Title		A randomised phase II feasibility study of Docetaxel (Taxotere®) plus Prednisolone vs. Docetaxel (Taxotere®) plus Prednisolone plus Zoledronic acid (Zometa®) vs. Docetaxel (Taxotere®) plus prednisolone plus Strontium-89 vs. Docetaxel (Taxotere®) plus Prednisolone plus Zoledronic acid (Zometa®) plus Strontium-89 in Hormone Refractory Prostate Cancer metastatic to bone.
Trial Start Date		2005-02-04
Trial Completion Date		2008-12-01 (estimated)
Registered in ClinicalTrials.gov		NCT00554918
Date Submitted to PDQ		2007-10-26
Information Last Verified		2008-04-06

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