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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer

Keywords

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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

Study Design

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Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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tamoxifen citrate

Intervention Type DRUG

diagnostic laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Gordon J.S. Rustin, MD

Role: STUDY_CHAIR

Mount Vernon Cancer Centre at Mount Vernon Hospital

Identifier Source: secondary_id

EU-205113

Identifier Type: -

Identifier Source: secondary_id

NCRN-1509

Identifier Type: -

Identifier Source: secondary_id

MREC-EC2003-62

Identifier Type: -

Identifier Source: secondary_id

CDR0000463518

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

tamoxifen citrate

diagnostic laboratory biomarker analysis

Eligibility Criteria

Inclusion Criteria

Sponsors

Mount Vernon Cancer Centre at Mount Vernon Hospital

Principal Investigators

Gordon J.S. Rustin, MD

Locations

Queen's Hospital

Chelmsford and Essex Centre

Royal Derby Hospital

St. Luke's Cancer Centre at Royal Surrey County Hospital

Ipswich Hospital

Airedale General Hospital

Leeds Cancer Centre at St. James's University Hospital

Liverpool Women's Hospital

Saint Bartholomew's Hospital

Clatterbridge Centre for Oncology

Mount Vernon Cancer Centre at Mount Vernon Hospital

Kings Mill Hospital

Oxford Radcliffe Hospital

Wexham Park Hospital

Southampton General Hospital

Great Western Hospital

Hillingdon Hospital

NHS Grampian

Aberdeen Royal Infirmary

North Glasgow University Hospitals NHS Trust

Ysbyty Gwynedd

Velindre Cancer Center at Velindre Hospital

Glan Clwyd Hospital

Wrexham Maelor Hospital

Countries

Facility Contacts

Mojca Persic

Contact Person

Mojca Persic

Thomas

Jamie S. Morgan, MBBS, FRCR, MRCP

S. Michael Crawford, MD

Tim J. Perren, MD

John A. Green, MD

Christopher J. Gallagher, MD

John A. Green, MD

Gordon J.S. Rustin, MD

Santhanam Sundar

T.S. Ganesan, MD

Marcia Hall, MD

Contact Person

Amanda Horne

Contact Person

David Parkin

Contact Person

Nicholas S. Reed, MD

Contact Person

Malcolm Adams, MD

Contact Person

Contact Person

Other Identifiers

CDR0000463518

EU-205113

NCRN-1509

MREC-EC2003-62

CDR0000463518