A Multi-center Phase II Study of Doxil®/Carboplatin in Patients With Advanced or Recurrent Endometrial Carcinoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed primary endometrial carcinoma meeting 1 of the following
criteria:

- Stage III or IV disease according to FIGO staging criteria

- Recurrent disease that is considered incurable

- Measurable disease

- A lesion within a previously irradiated field is acceptable as measurable
disease only if there has been clear progression since completion of
radiotherapy

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 g/dL

- Creatinine < 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min

- ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of
liver metastases)

- Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver
metastases)

- Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)

- Not pregnant or nursing

- Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO

- No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome

- No other invasive malignancy (i.e., breast cancer) within the past 5 years except
nonmelanoma skin cancer

- No cardiac disease, including any of the following:

- Myocardial infarction within the past 6 months

- NYHA class II-IV heart failure

- Uncontrolled angina

- Severe uncontrolled ventricular arrhythmias

- Clinically significant pericardial disease

- Acute ischemic or active conduction system abnormalities by ECHO

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy

- No prior cancer therapy that would contraindicate study treatment

- No concurrent investigational agents