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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Correlative studies
Given IV
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Frequency and duration of objective response
Time frame: Up to 5 years
Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
Time frame: Up to 5 years
Duration of progression-free survival
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Time frame: From study entry until disease progression, death or date or last contact, assessed up to 5 years
Duration of overall survival
Will be evaluated with non-parametric statistics (such as the log-rank test) through comparisons with the historical controls.
Time frame: From study entry to death or date or last contact, assessed up to 5 years
Prognostic factors (i.e., initial performance status and histological grade)
Comparisons will be made through a Cox model, which allows for adjustments with the prognostic variables.
Time frame: Not Provided
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