Trisenox® in Women With Metastatic Endometrial Cancer (NCT01184053) | Clinical Trial Compass
TerminatedPhase 2
Trisenox® in Women With Metastatic Endometrial Cancer
Stopped: Accrual was very low. No subject had been enrolled in a year.
United States3 participantsStarted 2010-03
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. ≥18 years of age with histologically confirmed metastatic or recurrent endometrial cancer
✓. Documented progression of their endometrial cancer (i.e., within the last 3 months)
✓. If of childbearing potential they must agree to use approved barrier methods of contraception
✓. Presence of at least one measurable lesion that:
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
✓. Minimum life expectancy of 3 months
✓. Adequate renal and hepatic function (per study protocol guidelines)
✓. Adequate bone marrow function (per study protocol guidelines)
Exclusion criteria
✕. Women who are pregnant or lactating
✕. Presence of brain metastases
✕. Two or more prior cycles of cytotoxic chemotherapy since recurrence (Two total regimens are allowed if one includes adjuvant therapy.)
✕. Prior therapy with Trisenox or known sensitivity to this agent
✕. Prior anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of Trisenox.
What they're measuring
1
Objective Response (CR+PR) Rate of Subjects Given Trisenox