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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT00006903
Eligibility Criteria:
Criteria:
* Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that is not curable with surgery or radiotherapy
* Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry
* ER positive or negative allowed
* Measurable disease:
* At least 1 target lesion not within a previously irradiated field OR irradiated target lesion with clear disease progression
* At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, MRI, OR at least 10 mm by spiral CT scan
* Performance status:
* GOG 0-1
* Hematopoietic:
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor deficiency, or requirement for anticoagulants)
* Hepatic:
* Bilirubin =\< 1.5 times upper limit of normal (ULN)
* SGOT =\< 3 times ULN
* Alkaline phosphatase =\< 3 times ULN
* Renal:
* Creatinine =\< 2 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to castor oil
* No other concurrent malignancy except nonmelanoma skin cancer
* No other prior malignancy within past 5 years
* No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer
* No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that has subsequently recurred
* At least 3 weeks since prior hormonal therapy and recovered
* At least 3 weeks since prior radiotherapy and recovered
* At least 3 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00006903
Study Brief:
Protocol Section:
NCT00006903