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

Alternate Title

Phase II Study of CA 125 Doubling Time in Patients With Relapsed Advanced Ovarian Carcinoma, Fallopian Tube Carcinoma, or Primary Peritoneal Carcinoma Receiving Tamoxifen Citrate

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Diagnostic, Treatment	Active	Not specified	Other	MTVERNHOSP-CA125 EU-205113, NCRN-1509, MREC-EC2003-62, NCT00305838

Trial Description

Purpose:

Estrogen may cause the growth of ovarian cancer cells. Hormone therapy using tamoxifen may fight ovarian cancer by blocking the use of estrogen by the tumor cells. Measuring CA 125 levels may help doctors predict a patient's response to tamoxifen and help plan the best treatment.

This phase II trial is studying CA 125 levels in treating patients with relapsed advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who are receiving tamoxifen.

Eligibility:

Eligibility criteria include the following:

• Have finished treatment for first relapse
• 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 undergo blood collection once a month until the CA 125 level rises. They will then undergo blood collection every 2 weeks until CA 125 levels reach a certain level. Patients will then receive tamoxifen by mouth once a day for up to 3-6 months. Blood will continue to be collected every 2 weeks during treatment.

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

Mount Vernon Cancer Centre at Mount Vernon Hospital

Gordon Rustin, MD, Protocol chair		Ph: 44-1923-844-389 Email: grustin@nhs.net

United Kingdom
England
	Burton-upon-Trent
	Queen's Hospital
		Mojca Persic	Ph:  44-1283-566-333
			Email: mojca.persic@derbyhospitals.nhs.uk
	Chelmsford
	Chelmsford and Essex Centre
		Contact Person	Ph:  44-1245-513-044
	Derby
	Derby City General Hospital
		Mojca Persic	Ph:  44-1332-347-141
	Guildford
	St. Luke's Cancer Centre at Royal Surrey County Hospital
		Thomas	Ph:  44-1483-571-122
	Ipswich
	Ipswich Hospital
		Jamey Morgan, MBBS, FRCR, MRCP	Ph:  44-1473-704-910
			Email: Jamie.Morgan@ipswichhospital.nhs.uk
	Keighley
	Airedale General Hospital
		S. Michael Crawford, MD	Ph:  44-1535-652-511
			Email: michael.crawford@anhst.nhs.uk
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Tim Perren, MD	Ph:  44-113-206-4670
			Email: t.j.perren@leeds.ac.uk
	Liverpool
	Liverpool Women's Hospital
		John Green, MD	Ph:  44-151-708-9988
	London
	Saint Bartholomew's Hospital
		Christopher Gallagher, MD	Ph:  44-20-7601-8521
			Email: chris.gallagher@bartsandthelondon.nhs.uk
	Merseyside
	Clatterbridge Centre for Oncology
		John Green, MD	Ph:  44-151-482-7743
			Email: john.green@ccotrust.nhs.uk
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Gordon Rustin, MD	Ph:  44-1923-844-389
			Email: grustin@nhs.net
	Nottinghamshire
	Kings Mill Hospital
		Santhanam Sundar	Ph:  44-162-362-2515
	Oxford
	Oxford Radcliffe Hospital
		T.S. Ganesan, MD	Ph:  44-1865-222-458
			Email: ganesan@cancer.org.uk
	Slough, Berkshire
	Wexham Park Hospital
		Marcia Hall, MD	Ph:  44-1753-634-364
			Email: marcia.hall@nhs.net.uk
	Southampton
	Southampton General Hospital
		Contact Person	Ph:  44-23-8079-8751
	Swindon
	Great Western Hospital
		Amanda Horne	Ph:  44-1793-604-020
			Email: amanda.horne@orh.nhs.uk
	Uxbridge
	Hillingdon Hospital
		Contact Person	Ph:  44-1923-844-190
Scotland
	Aberdeen
	Aberdeen Royal Infirmary
		Contact Person	Ph:  44-1224-553-659
	NHS Grampian
		David Parkin	Ph:  44-122-455-3659
	Glasgow
	North Glasgow University Hospitals NHS Trust
		Nicholas Reed, MD	Ph:  44-141-301-7057
			Email: nick.reed@northglasgow.scot.nhs.uk
Wales
	Bangor
	Ysbyty Gwynedd
		Contact Person	Ph:  44-1248-384-331
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Malcolm Adams, MD	Ph:  44-29-2061-5888 ext. 6204
	Rhyl, Denbighshire
	Glan Clwyd Hospital
		Contact Person	Ph:  44-1745-583-910
	Wrexham
	Wrexham Maelor Hospital
		Contact Person	Ph:  44-1978-291-100

Registry Information
Official Title		Use of Changes in CA 125 Doubling Time to Detect Activity of Cytostatic Agents in Women Relapsing with Ovarian Carcinoma. Study 1-Tamoxifen
Trial Start Date		2004-03-03
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00305838
Date Submitted to PDQ		2005-12-09
Information Last Verified		2009-06-21

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