A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
OBJECTIVES: Primary I. Determine the antitumor cytostatic activity of thalidomide, as
measured by the probability of progression-free survival (PFS) for at least 6 months, in
patients with recurrent or persistent uterine carcinosarcoma.
II. Determine the nature and degree of toxicity of this drug in these patients.
Secondary I. Determine the partial and complete response rates in patients treated with this
II. Determine the duration of PFS and overall survival of patients treated with this drug.
III. Determine the effect of this drug on initial performance status and histological grade
in these patients.
IV. Correlate serum and plasma biomarkers, including vascular endothelial growth factor and
basic fibroblast growth factor, with clinical outcome (i.e., PFS) in patients treated with
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
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients alive
D. Scott McMeekin
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|