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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (24 locations)

    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