CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Malignant Tumor of Peritoneum |
Drug: tamoxifen citrate Other: laboratory biomarker analysis |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
- Percentage of patients who have a log linear rise in CA 125 levels [ Designated as safety issue: No ]
- Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve [ Designated as safety issue: No ]
- Comparison of the serial doubling time before and after commencing tamoxifen [ Designated as safety issue: No ]
- Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Queen's Hospital | Recruiting |
| Burton-upon-Trent, England, United Kingdom, DE13 0RB | |
| Contact: Mojca Persic 44-1283-566-333 mojca.persic@derbyhospitals.nhs.uk | |
| Chelmsford and Essex Centre | Recruiting |
| Chelmsford, England, United Kingdom, CM2 0QH | |
| Contact: Contact Person 44-1245-513-044 | |
| Derby City General Hospital | Recruiting |
| Derby, England, United Kingdom, DE22 3NE | |
| Contact: Mojca Persic 44-1332-347-141 | |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | Recruiting |
| Guildford, England, United Kingdom, GU2 7XX | |
| Contact: Thomas 44-1483-571-122 | |
| Ipswich Hospital | Recruiting |
| Ipswich, England, United Kingdom, IP4 5PD | |
| Contact: Jamie S. Morgan, MBBS, FRCR, MRCP 44-1473-704-910 Jamie.Morgan@ipswichhospital.nhs.uk | |
| Airedale General Hospital | Recruiting |
| Keighley, England, United Kingdom, BD20 6TD | |
| Contact: S. Michael Crawford, MD 44-1535-652-511 michael.crawford@anhst.nhs.uk | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Tim J. Perren, MD 44-113-206-4670 t.j.perren@leeds.ac.uk | |
| Liverpool Women's Hospital | Recruiting |
| Liverpool, England, United Kingdom, LV8 7SS | |
| Contact: John A. Green, MD 44-151-708-9988 | |
| Saint Bartholomew's Hospital | Recruiting |
| London, England, United Kingdom, EC1A 7BE | |
| Contact: Christopher J. Gallagher, MD 44-20-7601-8521 chris.gallagher@bartsandthelondon.nhs.uk | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: John A. Green, MD 44-151-482-7743 john.green@ccotrust.nhs.uk | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: Gordon J.S. Rustin, MD 44-1923-844-389 grustin@nhs.net | |
| Kings Mill Hospital | Recruiting |
| Nottinghamshire, England, United Kingdom, NG17 4JL | |
| Contact: Santhanam Sundar 44-162-362-2515 | |
| Oxford Radcliffe Hospital | Recruiting |
| Oxford, England, United Kingdom, 0X3 9DS | |
| Contact: T.S. Ganesan, MD 44-1865-222-458 ganesan@cancer.org.uk | |
| Wexham Park Hospital | Recruiting |
| Slough, Berkshire, England, United Kingdom, SL2 4HL | |
| Contact: Marcia Hall, MD 44-1753-634-364 marcia.hall@nhs.net.uk | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Contact Person 44-23-8079-8751 | |
| Great Western Hospital | Recruiting |
| Swindon, England, United Kingdom, SN3 6BB | |
| Contact: Amanda Horne 44-1793-604-020 amanda.horne@orh.nhs.uk | |
| Hillingdon Hospital | Recruiting |
| Uxbridge, England, United Kingdom, UB8 3NN | |
| Contact: Contact Person 44-1923-844-190 | |
| Aberdeen Royal Infirmary | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: Contact Person 44-1224-553-659 | |
| NHS Grampian | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZB | |
| Contact: David Parkin 44-122-455-3659 | |
| North Glasgow University Hospitals NHS Trust | Recruiting |
| Glasgow, Scotland, United Kingdom, G21 3UR | |
| Contact: Nicholas S. Reed, MD 44-141-301-7057 nick.reed@northglasgow.scot.nhs.uk | |
| Ysbyty Gwynedd | Recruiting |
| Bangor, Wales, United Kingdom, LL57 2PW | |
| Contact: Contact Person 44-1248-384-331 | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF4 7XL | |
| Contact: Malcolm Adams, MD 44-29-2061-5888 ext. 6204 | |
| Glan Clwyd Hospital | Recruiting |
| Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ | |
| Contact: Contact Person 44-1745-583-910 | |
| Wrexham Maelor Hospital | Recruiting |
| Wrexham, Wales, United Kingdom, LL13 7TD | |
| Contact: Contact Person 44-1978-291-100 | |
| Study Chair: | Gordon J.S. Rustin, MD | Mount Vernon Cancer Centre at Mount Vernon Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00305838 History of Changes |
| Other Study ID Numbers: | CDR0000463518, MTVERNHOSP-CA125, EU-205113, NCRN-1509, MREC-EC2003-62 |
| Study First Received: | March 21, 2006 |
| Last Updated: | March 4, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013