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

There is no location for this trial

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

Health 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
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
This is available on the Clinicaltrials.gov website
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
Trial Location(s)
St. James University Hospital
Leeds
LS9 7TF
Southampton General Hospital
Southampton
England
SO16 6YD
Dr Lakmali Sugathapala
Derby
DE22 3NE
St. Bartholomew's and The Royal London Hospital
London
EC1A 7BE
GSK Investigational Site
Ipswich
IP4 5PD
Novartis Investigative Site
Uxbridge
UB8 3NN
Clatterbridge Centre for Oncology
Merseyside
England
CH63 4JY
Aberdeen Royal Infirmary
Aberdeen
Scotland
AB25 2ZN
Aberdeen
AB25 2ZB
Ysbyty Gwynedd
Bangor
Wales
LL57 2PW
Velindre Hospital
Cardiff
Wales
CF4 7XL
The Royal Surrey County Hospital NHS Foundation Trust
Guildford
Surrey
GU2 7XX
Research Site
Northwood
Middlesex
HA6 2RN
King's Mills Hospital
Nottinghamshire
England
NG17 4JL
North Glasgow University Hospitals NHS Trust
Glasgow
Scotland
G21 3UR
Glan Clwyd Hospital
Rhyl, Denbighshire
Wales
LL 18 5UJ
Keighley
BD20 6TD
Wrexham Maelor Hospital
Wrexham
Wales
LL13 7TD
Novartis Investigative Site
Swindon
SN3 6BB
Wexham Park Hospital
Slough, Berkshire
England
SL2 4HL
Queen's Hospital
Burton-upon-Trent
England
DE13 0RB
Liverpool Women's Hospital
Liverpool
England
LV8 7SS
Chelmsford and Essex Centre
Chelmsford
England
CM2 0QH
(705) John Radcliffe Hospital
Oxford
England
0X3 9DS
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
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 2009

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

21 Mar 2006

Last Updated

09 Aug 2013