• Frequency and duration of objective response [ Designated as safety issue: No ]
• The frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

• Frequency and duration of objective response
• The frequency and severity of observed adverse effects

• Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
• Prognostic factors (i.e., initial performance status and histological grade) [ Designated as safety issue: No ]

• Duration of progression-free survival and overall survival
• Prognostic factors (i.e., initial performance status and histological grade)

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.

OBJECTIVES:

Primary

• 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.
• Determine the toxicity of this regimen in these patients.

Secondary

• Determine the progression-free and overall survival of patients treated with this regimen.
• 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.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Renal:

• Creatinine ≤ 1.5 times ULN

Cardiovascular:

• 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

Pulmonary:

• No requirement for supplemental oxygen at rest or with ambulation

Other:

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• 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

Chemotherapy:

• 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

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at the malignant tumor

• No concurrent hormonal therapy

  • Continuation of hormone replacement therapy allowed

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
• No concurrent radiotherapy

Surgery:

• Recovered from prior recent surgery

Other

• At least 3 weeks since any prior therapy directed at the malignant tumor
• No prior cancer treatment that would contraindicate study therapy