POEM STUDY: A Phase IIa Trial in Endometrial Carcinoma With Temsirolimus

Inclusion Criteria: 1. Patients must have histologically-confirmed endometrial cancer 2. Stage I - II (grade 1, 2 or 3), candidates for surgery as the primary treatment 3. Age ≥ 18 years 4. WHO performance status ≤ 2 5. Adequate bone marrow function 6. Adequate liver function 7. Adequate renal function 8. Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN 9. Signed informed consent Exclusion Criteria: 1. Subjects who have received prior anticancer therapies for the current endometrial cancer 2. Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study 3. Prior treatment with any investigational drug within the preceding 4 weeks 4. Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent 5. Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period 6. Uncontrolled brain or leptomeningeal metastases 7. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin 8. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study 9. Patients with an active, bleeding diathesis 10. Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods 11. Patients who have received prior treatment with an mTOR inhibitor 12. Patients with a known hypersensitivity to rapamycine derivates or to its excipients 13. History of noncompliance to medical regimens 14. Patients unwilling to or unable to comply with the study protocol