NCT00096447

Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation Of Lapatinib (GW572016) (NCI-Supplied Agent, NSC #727989) In The Treatment Of Persistent Or Recurrent Endometrial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well lapatinib works in treating patients with recurrent or persistent endometrial cancer. Lapatinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth

Detailed description

PRIMARY OBJECTIVES: I. Determine the 6-month progression-free survival of patients with recurrent or persistent endometrial carcinoma treated with lapatinib. II. Determine the nature and degree of toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the objective response rate in patients treated with this drug. II. Determine the duration of progression-free survival and overall survival in patients treated with this drug. III. Determine the effects of prognostic factors, such as initial performance status and tumor grade, in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral lapatinib 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 and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 22-82 patients will be accrued for this study within 30-67 months.

Conditions

• Recurrent Endometrial Carcinoma

Interventions

Type	Name	Description
DRUG	lapatinib ditosylate

Timeline

• Start date: 2004-11-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2004-11-10
• Last updated: 2019-07-24
• Results posted: 2015-09-18

Locations

1 site across 1 country: United States