Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Endometrial Adenocarcinoma, ERBB2 Gene Amplification, Recurrent Uterine Corpus Carcinoma

About this trial
This is an interventional treatment trial for Endometrial Adenocarcinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed endometrial adenocarcinoma Advanced, recurrent, or persistent disease Refractory to curative therapy HER2/neu gene amplification by fluorescent in situ hybridization Measurable disease Previously irradiated field as sole site of measurable disease allowed if evidence of progression since completion of radiotherapy Performance status - GOG 0-2 Absolute neutrophil count ? 1,500/mm^3 Platelet count ? 100,000/mm^3 Bilirubin ? 1.5 times upper limit of normal (ULN) Creatinine ? 1.5 times ULN LVEF ? 45% by echocardiogram or MUGA History of coronary artery disease and/or congestive heart failure allowed if medical management of condition has been stable within the past 6 months No active or unstable cardiac disease No active angina No myocardial infarction within the past 6 months No requirement for supplemental oxygen at rest or with ambulation Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection requiring antibiotics No uncontrolled infection No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No other unstable medical condition that would preclude study participation At least 3 weeks since prior biologic and immunologic agents directed at the malignant tumor No prior anti-HER2 monoclonal antibody preparation No other concurrent immunotherapy Recovered from prior chemotherapy Multiple prior chemotherapy regimens allowed No more than 320 mg/m^2 total dose of prior doxorubicin allowed (including doxorubicin HCl liposome or other liposomally encapsulated doxorubicin preparations) No concurrent chemotherapy At least 1 week since prior hormonal therapy directed at the malignant tumor No concurrent hormonal therapy Continuation of hormone replacement therapy allowed See Disease Characteristics At least 3 weeks since prior radiotherapy for the malignant tumor and recovered No concurrent radiotherapy Recovered from prior recent surgery At least 3 weeks since any prior therapy directed at the malignant tumor No prior cancer treatment that would contraindicate study therapy
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (trastuzumab)
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.