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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00025220
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date September 2001
Completion date July 2008

See also
  Status Clinical Trial Phase
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Completed NCT00025506 - Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus Phase 2
Completed NCT01220609 - Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy Phase 2
Terminated NCT01012297 - Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma Phase 3
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Completed NCT01098630 - Patient, Physician, and Nurse Factors Associated With Entry Onto Clinical Trials and Finishing Treatment in Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Completed NCT01247571 - Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00031629 - Combination Chemotherapy and Filgrastim or Pegfilgrastim in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT01637961 - Alisertib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Phase 2