NCT00025506

Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus

A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well thalidomide works in treating patients with carcinosarcoma of the uterus that has come back or that does not go to remission (decrease or disappear but may still be in the body) despite treatment. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Detailed description

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 drug. 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 this drug. 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. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.

Conditions

• Recurrent Uterine Corpus Sarcoma
• Uterine Carcinosarcoma

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Thalidomide	Given orally

Timeline

• Start date: 2001-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2003-01-27
• Last updated: 2019-07-24
• Results posted: 2015-05-27

Locations

1 site across 1 country: United States