Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT01100359
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of endometrial carcinoma, including any of the following cellular types:
* Mixed Mullerian carcinoma
* Serous carcinoma
* Clear cell carcinoma
* Primary advanced (FIGO stage III or stage IV) or metastatic recurrent disease
* Disease not curable by surgery
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm with x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm with spiral CT scan or MRI
* No known cerebral metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Platelet count ≥ 100,000/mm\^3
* ANC ≥ 1,500/mm\^3
* Hemoglobin ≥ 10 g/dL
* Creatinine ≤ 1.25 times upper limit of normal (ULN)
* Bilirubin ≤ 1.25 times ULN
* AST/ALT \< 3 times ULN
* Glomerular filtration rate ≥ 50 mL/min
* LVEF ≥ 50% by ECHO
* Fertile patients must use effective contraception
* No myocardial infarction within the past 6 months
* No NYHA class II-IV congestive heart failure
* No third degree or complete heart block unless a pacemaker is in place
* No other malignancy within the past 5 years
* No concomitant medical illness (e.g., uncontrolled infection, uncontrolled angina, or other relevant illness) that makes the prescribed treatments within this study unfeasible
* No known hypersensitivity to study drugs
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy for disease recurrence
* At least 12 months since prior adjuvant therapy containing anthracyclines with cumulative doses not exceeding the following:
* Epirubicin 600 mg/m²
* Doxorubicin 300 mg/m²
* At least 6 months since prior adjuvant therapy containing platinum
* At least 4 weeks since completion of radiotherapy involving the whole pelvis
* No concurrent radiotherapy or planned radiotherapy after study
* No concurrent endocrine, immunological, or other anticancer therapy
* No concurrent participation in another investigational drug study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01100359
Study Brief:
Protocol Section:
NCT01100359