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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Given orally
Correlative studies
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Proportion of patients alive and progression-free
Time frame: 6 months
Frequency of adverse events assessed by CTC
Time frame: Up to 6 years
Progression-free survival
Time frame: From study entry until disease progression, death, or date of last contact, assessed up to 6 years
Overall survival
Time frame: From entry into the study to death or the date of last contact, assessed up to 6 years
Frequency of clinical response using the GOG RECIST criteria
Time frame: Up to 6 years
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