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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
tamoxifen citrate
diagnostic laboratory biomarker analysis
Sponsored by
Mount Vernon Cancer Centre at Mount Vernon Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Queen's HospitalRecruiting
  • Chelmsford and Essex CentreRecruiting
  • Royal Derby HospitalRecruiting
  • St. Luke's Cancer Centre at Royal Surrey County HospitalRecruiting
  • Ipswich HospitalRecruiting
  • Airedale General HospitalRecruiting
  • Leeds Cancer Centre at St. James's University HospitalRecruiting
  • Liverpool Women's HospitalRecruiting
  • Saint Bartholomew's HospitalRecruiting
  • Clatterbridge Centre for OncologyRecruiting
  • Mount Vernon Cancer Centre at Mount Vernon HospitalRecruiting
  • Kings Mill HospitalRecruiting
  • Oxford Radcliffe HospitalRecruiting
  • Wexham Park HospitalRecruiting
  • Southampton General HospitalRecruiting
  • Great Western HospitalRecruiting
  • Hillingdon HospitalRecruiting
  • NHS GrampianRecruiting
  • Aberdeen Royal InfirmaryRecruiting
  • North Glasgow University Hospitals NHS TrustRecruiting
  • Ysbyty GwyneddRecruiting
  • Velindre Cancer Center at Velindre HospitalRecruiting
  • Glan Clwyd HospitalRecruiting
  • Wrexham Maelor HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 21, 2006
Last Updated
August 9, 2013
Sponsor
Mount Vernon Cancer Centre at Mount Vernon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00305838
Brief Title
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mount Vernon Cancer Centre at Mount Vernon Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Percentage of patients who have a log linear rise in CA 125 levels
Title
Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve
Title
Comparison of the serial doubling time before and after commencing tamoxifen
Title
Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon J.S. Rustin, MD
Organizational Affiliation
Mount Vernon Cancer Centre at Mount Vernon Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Queen's Hospital
City
Burton-upon-Trent
State/Province
England
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mojca Persic
Phone
44-1283-566-333
Email
mojca.persic@derbyhospitals.nhs.uk
Facility Name
Chelmsford and Essex Centre
City
Chelmsford
State/Province
England
ZIP/Postal Code
CM2 0QH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1245-513-044
Facility Name
Royal Derby Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mojca Persic
Phone
44-1332-347-141
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas
Phone
44-1483-571-122
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie S. Morgan, MBBS, FRCR, MRCP
Phone
44-1473-704-910
Email
Jamie.Morgan@ipswichhospital.nhs.uk
Facility Name
Airedale General Hospital
City
Keighley
State/Province
England
ZIP/Postal Code
BD20 6TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
S. Michael Crawford, MD
Phone
44-1535-652-511
Email
michael.crawford@anhst.nhs.uk
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim J. Perren, MD
Phone
44-113-206-4670
Email
t.j.perren@leeds.ac.uk
Facility Name
Liverpool Women's Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
LV8 7SS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John A. Green, MD
Phone
44-151-708-9988
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher J. Gallagher, MD
Phone
44-20-7601-8521
Email
chris.gallagher@bartsandthelondon.nhs.uk
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John A. Green, MD
Phone
44-151-482-7743
Email
john.green@ccotrust.nhs.uk
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gordon J.S. Rustin, MD
Phone
44-1923-844-389
Email
grustin@nhs.net
Facility Name
Kings Mill Hospital
City
Nottinghamshire
State/Province
England
ZIP/Postal Code
NG17 4JL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Santhanam Sundar
Phone
44-162-362-2515
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
T.S. Ganesan, MD
Phone
44-1865-222-458
Email
ganesan@cancer.org.uk
Facility Name
Wexham Park Hospital
City
Slough, Berkshire
State/Province
England
ZIP/Postal Code
SL2 4HL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia Hall, MD
Phone
44-1753-634-364
Email
marcia.hall@nhs.net.uk
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-23-8079-8751
Facility Name
Great Western Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Horne
Phone
44-1793-604-020
Email
amanda.horne@orh.nhs.uk
Facility Name
Hillingdon Hospital
City
Uxbridge
State/Province
England
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1923-844-190
Facility Name
NHS Grampian
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Parkin
Phone
44-122-455-3659
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1224-553-659
Facility Name
North Glasgow University Hospitals NHS Trust
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G21 3UR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas S. Reed, MD
Phone
44-141-301-7057
Email
nick.reed@northglasgow.scot.nhs.uk
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1248-384-331
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malcolm Adams, MD
Phone
44-29-2061-5888 ext. 6204
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1745-583-910
Facility Name
Wrexham Maelor Hospital
City
Wrexham
State/Province
Wales
ZIP/Postal Code
LL13 7TD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-1978-291-100

12. IPD Sharing Statement

Learn more about this trial

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

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