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

Phase 2

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

• Registration Number: NCT00305838
• Lead Sponsor: Mount Vernon Cancer Centre at Mount Vernon Hospital

Brief 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.

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 Timeline

• Study Start: 2004-03
• Study First Submitted: 2006-03-21
• Study First Submitted QC: 2006-03-21
• Study First Posted: 2006-03-22
• Primary Completion: 2008-12
• Status Verified: 2009-06
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (24)

Queen's Hospital; 🇬🇧 Burton-upon-Trent, England, United Kingdom

Chelmsford and Essex Centre; 🇬🇧 Chelmsford, England, United Kingdom

Royal Derby Hospital; 🇬🇧 Derby, England, 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

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