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

NCT00305838 | Unknown Phase 2

• 4 other identifiers: CDR0000463518EU-205113NCRN-1509MREC-EC2003-62
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 24

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.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

tamoxifen citrate DRUG

diagnostic laboratory biomarker analysis OTHER

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mount Vernon Cancer Centre at Mount Vernon Hospital: lead

Study Sites (24)

Queen's Hospital

Burton-on-Trent, England, DE13 0RB, United Kingdom

RECRUITING

Chelmsford and Essex Centre

Chelmsford, England, CM2 0QH, United Kingdom

RECRUITING

Royal Derby Hospital

Derby, England, DE22 3NE, United Kingdom

RECRUITING

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

Guildford, England, GU2 7XX, United Kingdom

RECRUITING

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

RECRUITING

Airedale General Hospital

Keighley, England, BD20 6TD, United Kingdom

RECRUITING

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

RECRUITING

Liverpool Women's Hospital

Liverpool, England, LV8 7SS, United Kingdom

RECRUITING

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

RECRUITING

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

RECRUITING

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

RECRUITING

Kings Mill Hospital

Nottinghamshire, England, NG17 4JL, United Kingdom

RECRUITING

Oxford Radcliffe Hospital

Oxford, England, 0X3 9DS, United Kingdom

RECRUITING

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

RECRUITING

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

RECRUITING

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

RECRUITING

Hillingdon Hospital

Uxbridge, England, UB8 3NN, United Kingdom

RECRUITING

NHS Grampian

Aberdeen, Scotland, AB25 2ZB, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

RECRUITING

North Glasgow University Hospitals NHS Trust

Glasgow, Scotland, G21 3UR, United Kingdom

RECRUITING

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

RECRUITING

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

RECRUITING

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

RECRUITING

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7TD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gordon J.S. Rustin, MD

  Mount Vernon Cancer Centre at Mount Vernon Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2006
• First Posted: March 22, 2006
• Study Start: March 1, 2004
• Primary Completion: December 1, 2008
• Last Updated: August 12, 2013

Record last verified: 2009-06

Locations

GB (24)