A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy
I. To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for
epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal carcinoma who
are in complete clinical remission following front-line treatment but have a high risk of
recurrence due to rising serum CA-125.
II. To compare the toxicities and complications of these treatments.
I. To determine whether changes in serum biomarker levels including VEGF and/or bFGF are
independent of the randomization treatment.
II. To determine whether serum and plasma biomarker levels including VEGF and/or bFGF are
associated with the duration of recurrence-free survival.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the
interval between completion of front-line chemotherapy and appearance of biochemical
progression (6 months or less vs more than 6 months). Patients are randomized to 1 of 2
ARM I: Patients receive oral thalidomide once daily on days 1-28.
ARM II: Patients receive oral tamoxifen twice daily on days 1-28.
In both arms, courses repeat every 28 days for up to 1 year in the absence of disease
progression or unacceptable toxicity. Patients may receive additional therapy beyond 1 year
at the investigator's discretion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Up to 8 years
Gynecologic Oncology Group
United States: Food and Drug Administration
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