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:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT00470067
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary endometrial carcinoma meeting 1 of the following criteria:
* Stage III or IV disease according to FIGO staging criteria
* Recurrent disease that is considered incurable
* Measurable disease
* A lesion within a previously irradiated field is acceptable as measurable disease only if there has been clear progression since completion of radiotherapy
PATIENT CHARACTERISTICS:
* GOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Creatinine \< 2.5 mg/dL OR creatinine clearance ≥ 60 mL/min
* ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN in the presence of liver metastases)
* Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
* Total bilirubin ≤ 1.5 times ULN (3 times ULN in the presence of liver metastases)
* Not pregnant or nursing
* Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA scan or ECHO
* No history of severe hypersensitivity reaction to doxorubicin hydrochloride liposome
* No other invasive malignancy (i.e., breast cancer) within the past 5 years except nonmelanoma skin cancer
* No cardiac disease, including any of the following:
* Myocardial infarction within the past 6 months
* NYHA class II-IV heart failure
* Uncontrolled angina
* Severe uncontrolled ventricular arrhythmias
* Clinically significant pericardial disease
* Acute ischemic or active conduction system abnormalities by ECHO
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy
* No prior cancer therapy that would contraindicate study treatment
* No concurrent investigational agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00470067
Study Brief:
Protocol Section:
NCT00470067