Conditions: Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 139
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Patients receive oral thalidomide once daily on days 1-28. arm 2: Patients receive oral tamoxifen twice daily on days 1-28.

Interventions: intervention 1: tamoxifen citrate intervention 2: thalidomide intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally intervention 3: Correlative studies

Protocol document: