Fallopian Tube Cancer Clinical Trial
Official title:
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
Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
treatment arms.
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
annually thereafter.
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