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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000463518 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-205113 | |||
| NCRN-1509 | |||
| MREC-EC2003-62 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tamoxifen citrate | Drug | |||
| diagnostic laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed advanced ovarian carcinoma, fallopian tube carcinoma, or primary peritoneal carcinoma
Completed therapy for first relapse
No significant cancer-related symptoms requiring urgent treatment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Gordon J.S. Rustin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's Hospital | Recruiting | Burton-on-Trent | England | DE13 0RB | United Kingdom |
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| Chelmsford and Essex Centre | Recruiting | Chelmsford | England | CM2 0QH | United Kingdom |
|
| Royal Derby Hospital | Recruiting | Derby | England | DE22 3NE | United Kingdom |
|
| St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting | Guildford | England | GU2 7XX | United Kingdom |
|
| Ipswich Hospital | Recruiting | Ipswich | England | IP4 5PD | United Kingdom |
|
| Airedale General Hospital | Recruiting | Keighley | England | BD20 6TD | United Kingdom |
|
| Leeds Cancer Centre at St. James's University Hospital | Recruiting | Leeds | England | LS9 7TF | United Kingdom |
|
| Liverpool Women's Hospital | Recruiting | Liverpool | England | LV8 7SS | United Kingdom |
|
| Saint Bartholomew's Hospital | Recruiting | London | England | EC1A 7BE | United Kingdom |
|
| Clatterbridge Centre for Oncology | Recruiting | Merseyside | England | CH63 4JY | United Kingdom |
|
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting | Northwood | England | HA6 2RN | United Kingdom |
|
| Kings Mill Hospital | Recruiting | Nottinghamshire | England | NG17 4JL | United Kingdom |
|
| Oxford Radcliffe Hospital | Recruiting | Oxford | England | 0X3 9DS | United Kingdom |
|
| Wexham Park Hospital | Recruiting | Slough, Berkshire | England | SL2 4HL | United Kingdom |
|
| Southampton General Hospital | Recruiting | Southampton | England | SO16 6YD | United Kingdom |
|
| Great Western Hospital | Recruiting | Swindon | England | SN3 6BB | United Kingdom |
|
| Hillingdon Hospital | Recruiting | Uxbridge | England | UB8 3NN | United Kingdom |
|
| NHS Grampian | Recruiting | Aberdeen | Scotland | AB25 2ZB | United Kingdom |
|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
|
| North Glasgow University Hospitals NHS Trust | Recruiting | Glasgow | Scotland | G21 3UR | United Kingdom |
|
| Ysbyty Gwynedd | Recruiting | Bangor | Wales | LL57 2PW | United Kingdom |
|
| Velindre Cancer Center at Velindre Hospital | Recruiting | Cardiff | Wales | CF4 7XL | United Kingdom |
|
| Glan Clwyd Hospital | Recruiting | Rhyl, Denbighshire | Wales | LL 18 5UJ | United Kingdom |
|
| Wrexham Maelor Hospital | Recruiting | Wrexham | Wales | LL13 7TD | United Kingdom |
|
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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