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 range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response (CR+PR) Rate of Subjects Given Trisenox
. 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.
. Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of ≤ grade 1 by NCI toxicity criteria)
. Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)