Endometrial Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma
Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor
OBJECTIVES:
I. Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month
progression-free survival, in patients with recurrent or persistent endometrial carcinoma.
II. Determine the nature and degree of toxicity of this drug in these patients. III.
Determine the partial and complete response rates in patients treated with this drug.
IV. Determine the duration of progression-free and overall survival in patients treated with
this drug.
V. Determine the effect of this drug on initial performance status and histological grade in
these patients.
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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