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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00305838
• Other study ID #: CDR0000463518
• Secondary ID: CDR0000463518EU-
• Status: Recruiting
• Phase: Phase 2
• First received: March 21, 2006
• Last updated: August 9, 2013
• Start date: March 2004

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• tamoxifen citrate

Other:
• diagnostic laboratory biomarker analysis

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	NHS Grampian	Aberdeen	Scotland
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Queen's Hospital	Burton-upon-Trent	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Chelmsford and Essex Centre	Chelmsford	England
United Kingdom	Royal Derby Hospital	Derby	England
United Kingdom	North Glasgow University Hospitals NHS Trust	Glasgow	Scotland
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Airedale General Hospital	Keighley	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Liverpool Women's Hospital	Liverpool	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Kings Mill Hospital	Nottinghamshire	England
United Kingdom	Oxford Radcliffe Hospital	Oxford	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Wexham Park Hospital	Slough, Berkshire	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	Great Western Hospital	Swindon	England
United Kingdom	Hillingdon Hospital	Uxbridge	England
United Kingdom	Wrexham Maelor Hospital	Wrexham	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Mount Vernon Cancer Centre at Mount Vernon Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who have a log linear rise in CA 125 levels			No
Primary	Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve			No
Primary	Comparison of the serial doubling time before and after commencing tamoxifen			No
Primary	Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen			No