Status:
UNKNOWN
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
Lead Sponsor:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Conditions:
Fallopian Tube Cancer
Ovarian Cancer
Eligibility:
FEMALE
Phase:
PHASE2
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 m...
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. * D...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00305838
Start Date
March 1 2004
Last Update
August 12 2013
Active Locations (24)
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1
Queen's Hospital
Burton-on-Trent, England, United Kingdom, DE13 0RB
2
Chelmsford and Essex Centre
Chelmsford, England, United Kingdom, CM2 0QH
3
Royal Derby Hospital
Derby, England, United Kingdom, DE22 3NE
4
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, United Kingdom, GU2 7XX