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Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary (NCT00003865)

RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen. PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer.
  • Drug: toremifene
    Ages eligible for Study
    18 Years to 120 Years
    Genders eligible for Study
    Female
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Determine the effects of toremifene in terms of response rate, duration of response, duration of survival, and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary.

    - Assess whether a dose response effect is likely for this regimen in these patients.

    - Assess quality of life of these patients.

    OUTLINE: This is a randomized study.

    Patients receive one of two doses of oral toremifene daily for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

    Quality of life is assessed before therapy and then every 4 weeks during therapy.

    Patients are followed every 12 weeks until death.

    PROJECTED ACCRUAL: The study was closed before any patient accrual.

    1 locations

    United States (1)
    • George Washington University Cancer Center
      Washington, D.C., District of Columbia, United States, 20037
    Status:
    withdrawn
    Type:
    Interventional
    Phase:
    Start:
    21 July, 1999
    Updated:
    10 July, 2017
    Participants:
    0
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