Clinical Trials Directory

Trials / Completed

CompletedNCT00025467

Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of Thalidomide (NSC #66847, IND 48832) in the Treatment of Recurrent of Persistent Endometrial Carcinoma

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

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DRUGthalidomideGiven orally
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2001-09-01
Primary completion
2007-07-01
First posted
2003-10-15
Last updated
2013-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00025467. Inclusion in this directory is not an endorsement.