Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen

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

Objectives

1. Determine the percentage of patients with relapsed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma who have a log linear rise in CA 125 levels.
2. Determine whether the log linear part of the curve is consistent enough to allow comparison of the slope before and after introduction of a new therapy.
3. Compare the serial doubling time before and after commencing tamoxifen citrate treatment.
4. Determine the number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen citrate treatment.

Entry Criteria

Disease Characteristics:

• Histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma



• Completed therapy for first relapse
  • Had an elevated CA 125 level before starting relapse therapy with ≥ 50% fall by completion of that therapy or response according to RECIST criteria



• No significant cancer-related symptoms requiring urgent treatment

Prior/Concurrent Therapy:

• No other concurrent hormonal therapy, except hormone-replacement therapy
• Other concurrent medications allowed provided dose is stable

Patient Characteristics:

• ECOG performance status 0-2
• Life expectancy > 3 months
• Hemoglobin > 10 g/dL
• WBC > 2,500/mm³
• Platelet count > 100,000/mm³
• Creatinine < 2 times upper limit of normal (ULN)
• AST/ALT < 2 times ULN
• Bilirubin < 1.5 times ULN
• No evidence of significant clinical disorder or laboratory finding that would preclude study participation
• No psychiatric disorder that would preclude informed consent
• Not pregnant or nursing

Expected Enrollment

A total of 200 patients will be accrued for this study.

Outcomes

Percentage of patients who have a log linear rise in CA 125 levels
Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve
Comparison of the serial doubling time before and after commencing tamoxifen
Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen

Outline

Patients undergo blood collection once a month to measure CA 125 levels. Once the CA 125 level goes above the upper limit of normal (ULN) or has started to rise from its nadir level (if not previously normal), CA 125 levels are measured every 2 weeks. When CA 125 levels reach 4 times the ULN or 4 times the nadir level (if not previously normal), patients begin oral tamoxifen citrate once daily for 3-6 months in the absence of disease progression or unacceptable toxicity. CA 125 levels will continue to be measured every 2 weeks during treatment.

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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