Clinical Trial: Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer

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

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

Brief 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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome:

  • Proportion of patients alive and progression-free [ Time Frame: 6 months ]
  • Frequency of adverse events assessed by CTC [ Time Frame: Up to 6 years ]


Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 11, 2001
Date Started: September 2001
Date Completion:
Last Updated: January 23, 2013
Last Verified: January 2013