CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen | Recruiting
CA 125 Levels in Treating Patients With Relapsed Advanced Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer Who Are Receiving Tamoxifen
Health Conditions
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
Recruiting
Recruitment Status
NCT00305838
Primary Trial ID Number
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.
Primary Outcome Measures
  • Percentage of patients who have a log linear rise in CA 125 levels; null; Comparison of the slope before and after introduction of a new therapy in terms of consistency of the log linear part of the curve; null; Comparison of the serial doubling time before and after commencing tamoxifen; null; Number of patients required to detect a significant difference in CA 125 doubling time before and after starting tamoxifen; null
Secondary Outcome Measures
    Sorry, this information is not available
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Female
Participant Age Range
N/A to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
200
Participant 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
Participant Exclusion 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
Interventions
Drug; tamoxifen citrate; null; []; Other; diagnostic laboratory biomarker analysis; null; []
Design Details
Sorry, this information is not available
Study Design
Masking: Open Label, Primary Purpose: Diagnostic
Results Reporting
Sorry, this information is not available
Acronym
Sorry, this information is not available
Scientific Title
Use of Changes in CA 125 Doubling Time to Detect Activity of Cytostatic Agents in Women Relapsing With Ovarian Carcinoma. Study 1-Tamoxifen
Secondary Trial Identifying Number
CDR0000463518; EU-205113; NCRN-1509; MREC-EC2003-62
Website
http://cancer.gov/clinicaltrials/MTVERNHOSP-CA125
Study Funded By
Mount Vernon Cancer Centre at Mount Vernon Hospital
Funder Type
Sorry, this information is not available
Study Sponsored By
Mount Vernon Cancer Centre at Mount Vernon Hospital
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

21 Mar 2006

Last Updated

09 Aug 2013

Date Record Refreshed on UKCTG

31 Jul 2015