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 range18 Years
SexFEMALE
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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…
What they're measuring
1
Tumor Response Rate, in Terms of the Proportion of Confirmed Tumor Responses (CR or PR) Assessed Using RECIST