NCT00462826

VEGF Trap in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of VEGF-Trap (AFLIBERCEPT, NSC #724770, NCI-Supplied Agent) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying the side effects and how well VEGF Trap works in treating patients with recurrent or persistent endometrial cancer. VEGF Trap may stop the growth of endometrial cancer by blocking blood flow to the tumor and by carrying tumor-killing substances directly to endometrial cancer cells.

Detailed description

PRIMARY OBJECTIVES: I. Assess the activity of VEGF Trap in patients with recurrent or persistent endometrial cancer, in terms of the frequency of patients who have progression-free survival for at least 6 months after initiating therapy or have objective tumor response. II. Determine the toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the duration of progression-free survival and overall survival of patients treated with this drug. OUTLINE: Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Recurrent Endometrial Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	ziv-aflibercept

Timeline

• Start date: 2007-11-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2007-04-19
• Last updated: 2019-07-23
• Results posted: 2013-09-16

Locations

67 sites across 1 country: United States