CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00305838
- Lead Sponsor
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Brief Summary
RATIONALE: 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.
PURPOSE: 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.
- Detailed Description
OBJECTIVES:
* 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.
* 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.
* Compare the serial doubling time before and after commencing tamoxifen citrate treatment.
* Determine the number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen citrate treatment.
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.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve Percentage of patients who have a log linear rise in CA 125 levels 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Royal Derby Hospital
🇬🇧Derby, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, Wales, United Kingdom
Queen's Hospital
🇬🇧Burton-upon-Trent, England, United Kingdom
Airedale General Hospital
🇬🇧Keighley, England, United Kingdom
North Glasgow University Hospitals NHS Trust
🇬🇧Glasgow, Scotland, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, England, United Kingdom
Kings Mill Hospital
🇬🇧Nottinghamshire, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, England, United Kingdom
Chelmsford and Essex Centre
🇬🇧Chelmsford, England, United Kingdom
NHS Grampian
🇬🇧Aberdeen, Scotland, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Great Western Hospital
🇬🇧Swindon, England, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom