A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
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.
I. Determine the progression-free and overall survival of patients treated with this
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response
Up to 5 years
Gynecologic Oncology Group
United States: Food and Drug Administration
|Gynecologic Oncology Group||Philadelphia, Pennsylvania 19103|