NCT00006089

Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer

A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

Detailed description

PRIMARY OOBJECTIVES: I. Determine the antitumor activity of trastuzumab (Herceptin), in terms of response, in patients with advanced, recurrent, or persistent endometrial adenocarcinoma that demonstrates HER2/neu gene amplification by fluorescent in situ hybridization. II. Determine the toxicity of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine the progression-free and overall survival of patients treated with this regimen. II. Determine the effects of prognostic factors (i.e., initial performance status and histological grade) in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. 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 25-42 patients will be accrued for this study within 12 years.

Conditions

• Endometrial Adenocarcinoma
• ERBB2 Gene Amplification
• Recurrent Uterine Corpus Carcinoma
• Stage III Uterine Corpus Cancer AJCC v7
• Stage IV Uterine Corpus Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Trastuzumab	Given IV

Timeline

• Start date: 2000-09-18
• Primary completion: 2007-09-04
• Completion: 2010-01-31
• First posted: 2003-01-27
• Last updated: 2019-07-31

Locations

1 site across 1 country: United States