Trisenox® in Women With Metastatic Endometrial Cancer

Inclusion Criteria

• •1. ≥18 years of age with histologically confirmed metastatic or recurrent endometrial cancer
• •2. Documented progression of their endometrial cancer (i.e., within the last 3 months)
• •3. If of childbearing potential they must agree to use approved barrier methods of contraception
• •4. Presence of at least one measurable lesion that:
• •* Can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm with spiral CT scan (or otherwise at least twice the reconstruction interval for CT or MRI scans).
• •* Previously irradiated lesions may be considered to be measurable provided: 1) there has been documented progression of the lesion(s) since completion of radiotherapy, and 2) the criteria for measurability as outlined above are met.
• •5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• •6. Minimum life expectancy of 3 months
• •7. Adequate renal and hepatic function (per study protocol guidelines)
• •8. Adequate bone marrow function (per study protocol guidelines)
• •9. Serum cholesterol \<350 mg/dL and triglycerides \< 400 mg/dL
• •10. Able to understand and give written informed consent
• •11. Ejection fraction \>55% with no focal left ventricular wall motion abnormalities in patients with a history of coronary artery disease or a history of congestive heart failure.
• •15. Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluating the safety of the study drug
• •16. Prolonged absolute corrected QT interval (QTc) interval \> 500 msec
• •17. Underlying conduction disease that prevents measurement of QT interval
• •18. History of ventricular tachycardia or any cardiac arrhythmia requiring the placement of an automated intraventricular cardiac defibrillator.
• •19. Inability to discontinue therapy with class I or class III antiarrhythmic medications.
• •20. Inability to discontinue drugs known to be associated with a risk for torsades de pointes