Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the endometrium * Metastatic disease after first- or second-line chemotherapy * Previously treated with platinum-based therapy in the adjuvant or metastatic setting * Must have ≥ 1 measurable metastatic lesion outside previously irradiated areas * No locally recurrent resectable tumor * No uncontrolled brain metastases PATIENT CHARACTERISTICS: * WHO performance status 0-1 * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * Transaminases ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 1.5 times ULN * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other cancer within the past 3 years except for curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin carcinoma * No concurrent serious and/or uncontrolled disease that would preclude study participation, including any of the following: * Uncontrolled diabetes * Uncontrolled hypertension * Severe infection * Profound malnutrition * Unstable angina * NYHA class III-IV congestive heart failure * Ventricular arrhythmia * Coronary artery disease * Myocardial infarction within the past 6 months * Liver disease * Chronic renal failure * Progressive ulceration of the upper gastrointestinal tract * No hypersensitivity to everolimus, sirolimus, or lactose * No abnormalities ≥ grade 3 * No psychological, familial, social, or geographical reasons that would preclude study follow-up * No history of poor compliance to medical treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior experimental drugs (e.g., mTOR inhibitors) * More than 21 days since prior and no other concurrent chemotherapy, hormonal therapy, or antitumor therapy * More than 5 days since prior strong CYP3A4 inhibitors or inducers (e.g., rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, or telithromycin) * More than 30 days since other prior treatments * No concurrent participation in another clinical trial that would interfere with the objectives of this study * No concurrent anticoagulation, except for 1 mg of coumadin per day or low molecular weight heparin