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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00305838
First received: March 21, 2006
Last updated: August 9, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Drug: tamoxifen citrate
Other: diagnostic laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients who have a log linear rise in CA 125 levels [ Designated as safety issue: No ]
  • Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve [ Designated as safety issue: No ]
  • Comparison of the serial doubling time before and after commencing tamoxifen [ Designated as safety issue: No ]
  • Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: March 2004
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305838

Locations
United Kingdom
Queen's Hospital Recruiting
Burton-upon-Trent, England, United Kingdom, DE13 0RB
Contact: Mojca Persic    44-1283-566-333    mojca.persic@derbyhospitals.nhs.uk   
Chelmsford and Essex Centre Recruiting
Chelmsford, England, United Kingdom, CM2 0QH
Contact: Contact Person    44-1245-513-044      
Royal Derby Hospital Recruiting
Derby, England, United Kingdom, DE22 3NE
Contact: Mojca Persic    44-1332-347-141      
St. Luke's Cancer Centre at Royal Surrey County Hospital Recruiting
Guildford, England, United Kingdom, GU2 7XX
Contact: Thomas    44-1483-571-122      
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Jamie S. Morgan, MBBS, FRCR, MRCP    44-1473-704-910    Jamie.Morgan@ipswichhospital.nhs.uk   
Airedale General Hospital Recruiting
Keighley, England, United Kingdom, BD20 6TD
Contact: S. Michael Crawford, MD    44-1535-652-511    michael.crawford@anhst.nhs.uk   
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Tim J. Perren, MD    44-113-206-4670    t.j.perren@leeds.ac.uk   
Liverpool Women's Hospital Recruiting
Liverpool, England, United Kingdom, LV8 7SS
Contact: John A. Green, MD    44-151-708-9988      
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Christopher J. Gallagher, MD    44-20-7601-8521    chris.gallagher@bartsandthelondon.nhs.uk   
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: John A. Green, MD    44-151-482-7743    john.green@ccotrust.nhs.uk   
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, England, United Kingdom, HA6 2RN
Contact: Gordon J.S. Rustin, MD    44-1923-844-389    grustin@nhs.net   
Kings Mill Hospital Recruiting
Nottinghamshire, England, United Kingdom, NG17 4JL
Contact: Santhanam Sundar    44-162-362-2515      
Oxford Radcliffe Hospital Recruiting
Oxford, England, United Kingdom, 0X3 9DS
Contact: T.S. Ganesan, MD    44-1865-222-458    ganesan@cancer.org.uk   
Wexham Park Hospital Recruiting
Slough, Berkshire, England, United Kingdom, SL2 4HL
Contact: Marcia Hall, MD    44-1753-634-364    marcia.hall@nhs.net.uk   
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Contact Person    44-23-8079-8751      
Great Western Hospital Recruiting
Swindon, England, United Kingdom, SN3 6BB
Contact: Amanda Horne    44-1793-604-020    amanda.horne@orh.nhs.uk   
Hillingdon Hospital Recruiting
Uxbridge, England, United Kingdom, UB8 3NN
Contact: Contact Person    44-1923-844-190      
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Contact Person    44-1224-553-659      
NHS Grampian Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZB
Contact: David Parkin    44-122-455-3659      
North Glasgow University Hospitals NHS Trust Recruiting
Glasgow, Scotland, United Kingdom, G21 3UR
Contact: Nicholas S. Reed, MD    44-141-301-7057    nick.reed@northglasgow.scot.nhs.uk   
Ysbyty Gwynedd Recruiting
Bangor, Wales, United Kingdom, LL57 2PW
Contact: Contact Person    44-1248-384-331      
Velindre Cancer Center at Velindre Hospital Recruiting
Cardiff, Wales, United Kingdom, CF4 7XL
Contact: Malcolm Adams, MD    44-29-2061-5888 ext. 6204      
Glan Clwyd Hospital Recruiting
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Contact: Contact Person    44-1745-583-910      
Wrexham Maelor Hospital Recruiting
Wrexham, Wales, United Kingdom, LL13 7TD
Contact: Contact Person    44-1978-291-100      
Sponsors and Collaborators
Mount Vernon Cancer Centre at Mount Vernon Hospital
Investigators
Study Chair: Gordon J.S. Rustin, MD Mount Vernon Cancer Centre at Mount Vernon Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00305838     History of Changes
Other Study ID Numbers: CDR0000463518, CDR0000463518, EU-205113, NCRN-1509, MREC-EC2003-62
Study First Received: March 21, 2006
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 10, 2014