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

Trial Source

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Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Medical Conditions
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruiting
Recruitment Status
NCT00305838
Primary Trial ID Number

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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.
Research Details
  • 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.
Phase
Phase 2
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Study Type
Interventional
Intervention
Drug : tamoxifen citrate, Other : diagnostic laboratory biomarker analysis

Study Arm Groups : ,

Intervention Type
See Interventions above
Primary Outcome Measures
    Percentage of patients who have a log linear rise in CA 125 levels; null; Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve; null; Comparison of the serial doubling time before and after commencing tamoxifen; null; Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen; null
Secondary Outcome Measures
    Sorry, this information is not available
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
N/A - N/A
Who Can Participate
Patients
Number of Participants
200
Participant Inclusion 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood
England
HA6 2RN
Southampton General Hospital
Southampton
England
SO16 6YD
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
London
EC1A 7BE
Glan Clwyd Hospital
Rhyl
Wales
LL 18 5UJ
Ipswich Hospital NHS Trust - Department of Clinical Neurology
Ipswich
IP4 5PD
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Derby
DE22 3NE
Guildford
GU2 7XX
Swindon
SN3 6BB
Clatterbridge Centre for Oncology NHS Trust
Birkenhead
England
CH63 4JY
Hillingdon Hospital
Uxbridge
England
UB8 3NN
Ysbyty Gwynedd
Bangor
Wales
LL57 2PW
Liverpool Women's Hospital
England
LV8 7SS
Queens Hospital
Burton-on-Trent
England
DE13 0RB
Airedale General Hospital
Steeton
England
BD20 6TD
King's Mills Hospital
Sutton-in-Ashfield
England
NG17 4JL
Wexham Park Hospital
England
SL2 4HL
Wrexham Maelor Hospital
Wrexham
LL13 7TD
Velindre Cancer Center at Velindre Hospital
Wales
CF4 7XL
Glasgow
G21 3UR
Chelmsford and Essex Centre
Chelmsford
England
CM2 0QH
Oxford Radcliffe Hospital
Oxford
England
0X3 9DS
NHS Grampian
Aberdeen
Scotland
AB25 2ZB
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Use of Changes in CA 125 Doubling Time to Detect Activity of Cytostatic Agents in Women Relapsing With Ovarian Carcinoma. Study 1-Tamoxifen
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
CDR0000463518
Sponsor(s)
Mount Vernon Cancer Centre at Mount Vernon Hospital
Key Dates

Recruitment Start Date

Mar 2004

Recruitment End Date

Dec 2008

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

21 Mar 2006

Date updated in source

09 Aug 2013