Recurrent Uterine Corpus Carcinoma Clinical Trial
Official title:
Phase II Study of Faslodex ? in Recurrent/Metastatic Endometrial Carcinoma
This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.
PRIMARY OBJECTIVES:
I. Compare the probability of clinical response in estrogen receptor (ER)-positive vs
ER-negative patients with recurrent, persistent, or metastatic endometrial cancer treated
with fulvestrant.
II. Compare the relationship between response rate and intensity of receptor expression in
patients treated with this drug.
III. Determine the frequency and intensity of toxicity of this drug in these patients.
OUTLINE:
Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at
least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
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