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

August 9, 2013 updated by: Mount Vernon Cancer Centre at Mount Vernon Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Burton-upon-Trent, England, United Kingdom, DE13 0RB
        • Recruiting
        • Queen's Hospital
      • Chelmsford, England, United Kingdom, CM2 0QH
        • Recruiting
        • Chelmsford and Essex Centre
        • Contact:
          • Contact Person
          • Phone Number: 44-1245-513-044
      • Derby, England, United Kingdom, DE22 3NE
        • Recruiting
        • Royal Derby Hospital
        • Contact:
          • Mojca Persic
          • Phone Number: 44-1332-347-141
      • Guildford, England, United Kingdom, GU2 7XX
        • Recruiting
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
        • Contact:
          • Thomas
          • Phone Number: 44-1483-571-122
      • Ipswich, England, United Kingdom, IP4 5PD
      • Keighley, England, United Kingdom, BD20 6TD
      • Leeds, England, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Cancer Centre at St. James's University Hospital
        • Contact:
      • Liverpool, England, United Kingdom, LV8 7SS
        • Recruiting
        • Liverpool Women's Hospital
        • Contact:
          • John A. Green, MD
          • Phone Number: 44-151-708-9988
      • London, England, United Kingdom, EC1A 7BE
      • Merseyside, England, United Kingdom, CH63 4JY
        • Recruiting
        • Clatterbridge Centre for Oncology
        • Contact:
      • Northwood, England, United Kingdom, HA6 2RN
        • Recruiting
        • Mount Vernon Cancer Centre at Mount Vernon Hospital
        • Contact:
          • Gordon J.S. Rustin, MD
          • Phone Number: 44-1923-844-389
          • Email: grustin@nhs.net
      • Nottinghamshire, England, United Kingdom, NG17 4JL
        • Recruiting
        • Kings Mill Hospital
        • Contact:
          • Santhanam Sundar
          • Phone Number: 44-162-362-2515
      • Oxford, England, United Kingdom, 0X3 9DS
        • Recruiting
        • Oxford Radcliffe Hospital
        • Contact:
      • Slough, Berkshire, England, United Kingdom, SL2 4HL
        • Recruiting
        • Wexham Park Hospital
        • Contact:
      • Southampton, England, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital
      • Swindon, England, United Kingdom, SN3 6BB
        • Recruiting
        • Great Western Hospital
        • Contact:
      • Uxbridge, England, United Kingdom, UB8 3NN
        • Recruiting
        • Hillingdon Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1923-844-190
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary
        • Contact:
          • Contact Person
          • Phone Number: 44-1224-553-659
      • Aberdeen, Scotland, United Kingdom, AB25 2ZB
        • Recruiting
        • NHS Grampian
        • Contact:
          • David Parkin
          • Phone Number: 44-122-455-3659
      • Glasgow, Scotland, United Kingdom, G21 3UR
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Recruiting
        • Ysbyty Gwynedd
        • Contact:
          • Contact Person
          • Phone Number: 44-1248-384-331
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Recruiting
        • Velindre Cancer Center at Velindre Hospital
        • Contact:
          • Malcolm Adams, MD
          • Phone Number: 44-29-2061-5888 ext. 6204
      • Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
        • Recruiting
        • Glan Clwyd Hospital
      • Wrexham, Wales, United Kingdom, LL13 7TD
        • Recruiting
        • Wrexham Maelor Hospital
        • Contact:
          • Contact Person
          • Phone Number: 44-1978-291-100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Vernon Cancer Centre at Mount Vernon Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (ANTICIPATED)

December 1, 2008

Study Registration Dates

First Submitted

March 21, 2006

First Submitted That Met QC Criteria

March 21, 2006

First Posted (ESTIMATE)

March 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000463518 (REGISTRY: PDQ (Physician Data Query))
  • EU-205113
  • NCRN-1509
  • MREC-EC2003-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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