Trisenox® in Women With Metastatic Endometrial Cancer
Condition: Endometrial Carcinoma
MeSH terms: Endometrial Neoplasms
Intervention: Arsenic trioxide
Intervention description: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
Intervention MeSH terms: Arsenic Trioxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: endometrial; carcinoma; recurrent; metastatic; Trisenox; arsenic trioxide; Phase II; VEGF; gynecology; Lineberger; UNC; vascular endothelial growth factor; University of North Carolina at Chapel Hill

Summary:

      The primary purpose of this study is to see whether women who have already received
      chemotherapy for their endometrial cancer, or who have disease that has spread outside of the
      uterus, will respond to the drug arsenic trioxide (Trisenox®) as judged by shrinkage of their
      tumor.
    

Eligibility criteria:

        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.

        Exclusion Criteria:

          1. Women who are pregnant or lactating

          2. Presence of brain metastases

          3. Two or more prior cycles of cytotoxic chemotherapy since recurrence (Two total
             regimens are allowed if one includes adjuvant therapy.)

          4. Prior therapy with Trisenox or known sensitivity to this agent

          5. Prior anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological
             response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the
             first dose of Trisenox.

          6. Ongoing toxicity associated with prior anticancer therapy (except peripheral
             neuropathy of ≤ grade 1 by NCI toxicity criteria)

          7. Another primary malignancy within the past three years (except for non-melanoma skin
             cancer and cervical carcinoma in situ)

          8. Significant uncontrolled cardiovascular disease

          9. Active infection requiring systemic therapy

         10. Known HIV infection

         11. Treatment with any investigational agent within 4 weeks prior to the first dose of
             Trisenox

         12. Concurrent treatment with immunosuppressive agents other than prescribed
             corticosteroids

         13. Inadequate recovery from any prior surgical procedure or having undergone any major
             surgical procedure within 2 weeks prior to the first dose of Trisenox

         14. Patients having undergone recent placement of a central venous access port will be
             considered eligible if they have recovered

         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