Fallopian Tube CancerPhase 2NCT00305838
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
A Phase 2 study testing tamoxifen citrate and diagnostic laboratory biomarker analysis in people with Fallopian Tube Cancer and Ovarian Cancer, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 24 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- tamoxifen citrate and diagnostic laboratory biomarker analysis
- How many people
- 200 participants
- Where
- 24 sitesUnited Kingdom
- Study dates
- Mar 2004to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Hemoglobin > 10 g/dL
- WBC > 2,500/mm^3
- Platelet count > 100,000/mm^3
- 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
PRIOR CONCURRENT THERAPY:
- No other concurrent hormonal therapy, except hormone-replacement therapy
- Other concurrent medications allowed provided dose is stable
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United Kingdom24 sites, 24 recruiting
- Recruiting
NHS Grampian
Aberdeen, Scotland, AB25 2ZB
David Parkin, 44-122-455-3659
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Contact Person, 44-1224-553-659
- Recruiting
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Contact Person, 44-1248-384-331
- Recruiting
Queen's Hospital
Burton-on-Trent, England, DE13 0RB
Mojca Persic, 44-1283-566-333, mojca.persic@derbyhospitals.nhs.uk
- Recruiting
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF4 7XL
Malcolm Adams, MD, 44-29-2061-5888 ext. 6204
- Recruiting
Chelmsford and Essex Centre
Chelmsford, England, CM2 0QH
Contact Person, 44-1245-513-044
- Recruiting
Royal Derby Hospital
Derby, England, DE22 3NE
Mojca Persic, 44-1332-347-141
- Recruiting
North Glasgow University Hospitals NHS Trust
Glasgow, Scotland, G21 3UR
Nicholas S. Reed, MD, 44-141-301-7057, nick.reed@northglasgow.scot.nhs.uk
- Recruiting
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Thomas, 44-1483-571-122
- Recruiting
Ipswich Hospital
Ipswich, England, IP4 5PD
Jamie S. Morgan, MBBS, FRCR, MRCP, 44-1473-704-910, Jamie.Morgan@ipswichhospital.nhs.uk
- Recruiting
Airedale General Hospital
Keighley, England, BD20 6TD
S. Michael Crawford, MD, 44-1535-652-511, michael.crawford@anhst.nhs.uk
- Recruiting
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Tim J. Perren, MD, 44-113-206-4670, t.j.perren@leeds.ac.uk
- Recruiting
Liverpool Women's Hospital
Liverpool, England, LV8 7SS
John A. Green, MD, 44-151-708-9988
- Recruiting
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Christopher J. Gallagher, MD, 44-20-7601-8521, chris.gallagher@bartsandthelondon.nhs.uk
- Recruiting
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
John A. Green, MD, 44-151-482-7743, john.green@ccotrust.nhs.uk
- Recruiting
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Gordon J.S. Rustin, MD, 44-1923-844-389, grustin@nhs.net
- Recruiting
Kings Mill Hospital
Nottinghamshire, England, NG17 4JL
Santhanam Sundar, 44-162-362-2515
- Recruiting
Oxford Radcliffe Hospital
Oxford, England, 0X3 9DS
T.S. Ganesan, MD, 44-1865-222-458, ganesan@cancer.org.uk
- Recruiting
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Contact Person, 44-1745-583-910
- Recruiting
Wexham Park Hospital
Slough, Berkshire, England, SL2 4HL
Marcia Hall, MD, 44-1753-634-364, marcia.hall@nhs.net.uk
- Recruiting
Southampton General Hospital
Southampton, England, SO16 6YD
Contact Person, 44-23-8079-8751
- Recruiting
Great Western Hospital
Swindon, England, SN3 6BB
Amanda Horne, 44-1793-604-020, amanda.horne@orh.nhs.uk
- Recruiting
Hillingdon Hospital
Uxbridge, England, UB8 3NN
Contact Person, 44-1923-844-190
- Recruiting
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
Contact Person, 44-1978-291-100
About this study
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
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.
Read the 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.
- Being tested
- tamoxifen citrate, diagnostic laboratory biomarker analysis
- Keywords
- stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, recurrent primary peritoneal cavity cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifen citrateDrug
diagnostic laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startMar 2004
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gordon J.S. Rustin, MD, Study chair, Mount Vernon Cancer Centre at Mount Vernon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305838
- Sponsor's protocol ID
- CDR0000463518
- Other IDs
- CDR0000463518, EU-205113, NCRN-1509, MREC-EC2003-62
- Status last verified
- Jun 2009
- First submitted
- 21 Mar 2006
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00305838
- Acronym / sponsor ID
- CDR0000463518
- Keywords
- stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, recurrent fallopian tube cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mount Vernon Cancer Centre at Mount Vernon HospitalUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Dec 2008 (estimated)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tamoxifen citrate | Drug | – |
| diagnostic laboratory biomarker analysis | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gordon J.S. Rustin, MD study chair
Mount Vernon Cancer Centre at Mount Vernon Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tamoxifen citrate and diagnostic laboratory biomarker analysis in people with Fallopian Tube Cancer and Ovarian Cancer, run by Mount Vernon Cancer Centre at Mount Vernon Hospital at 24 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who have a log linear rise in CA 125 levels. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.