Everolimus in Treating Patients With Relapsed or Metastatic Endometrial Cancer (ENDORAD)

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