Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus (NCT01061606) | Clinical Trial Compass
TerminatedPhase 2
Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus
Stopped: Poor accrual
United States8 participantsStarted 2010-01
Plain-language summary
This phase II trial is studying how well temsirolimus works in treating patients with recurrent or persistent cancer of the uterus. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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:
* Histologically or cytologically confirmed Carcinosarcoma (MMMT)
* Measurable disease;
* Only one prior systemic treatments after primary adjuvant treatment for persistent or metastatic disease are permitted,
* Radiation therapy (adjuvant or palliative) must be completed ≥ 4 weeks prior to registration
* Required laboratory values obtained =\< 7 days prior to registration:
* Absolute Neutrophil Count (ANC) \>= 1500/mm\^3
* Platelets \>= 75,000/mm\^3
* Hemoglobin \>= 9.0 g/dL
* Direct bilirubin =\< 1.5 x upper limit of normal (ULN)
* Alkaline phosphatase =\< 2.5 x ULN (≤ 5 x ULN if liver metastasis is present)
* SGOT(AST) =\< 2.5 x ULN (≤ 5 x ULN if liver metastasis is present)
* Creatinine =\< 1.5 x ULN
* Fasting serum cholesterol ≤ 350mg/dL (9.0 mmol/L)
* Triglycerides ≤ 1.5 x ULN
* Patients with Triglyceride levels \> 1.5 x ULN can be started on lipid lowering agents and reevaluated within 1 week; if levels go to ≤ 1.5 x ULN, they can be considered for the trial and continue the lipid lowering agents
* International Normalized Ratio (INR) ≤ 1.5 (unless the patient is on full dose warfarin)
* ECOG Performance Status (PS) 0-1
* Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
* Full-dose anticoagulants, if a patient is receiving full-dose anticoagulants, the following criteria should be met for enrollment:
* The subject must have an in-range INR (usually betwee…
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
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST