Clinical Trial: Thalidomide in Treating Patients With Recurrent or Persistent Cancer of the Uterus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Brief Summary: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent cancer of the uterus. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

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 leiomyosarcoma.

II. Determine the nature and degree of the 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 PFS and overall survival of patients treated with this drug.

V. Determine the effect of this drug on initial performance status in these patients.

VI. Determine the effects of this drug at 4 weeks on endogenous angiogenesis factors (vascular endothelial growth factor and basic fibroblast growth factor) in plasma and urine of these patients.

VII. Assess the association of endogenous angiogenesis factors with clinical outcome (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 4 weeks 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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Progression-free survival [ Time Frame: 6 months ]
  • Frequency and severity of adverse effects as assessed by CTC [ Time Frame: Up to 7 years ]


Original Primary Outcome:

Current Secondary Outcome:

  • Duration of progression-free survival [ Time Frame: Up to 7 years ]
  • Duration of overall survival [ Time Frame: Up to 7 years ]
  • Frequency of clinical response (partial and complete response) [ Time Frame: Up to 7 years ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 11, 2001
Date Started: September 2001
Date Completion:
Last Updated: March 13, 2015
Last Verified: December 2012