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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00023894
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary endometrial carcinoma
* Recurrent or persistent disease
* Refractory to curative therapy or established treatment
* Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma
* Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* At least 1 target lesion outside previously irradiated field
* Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as any active GOG phase III protocol for the same patient population
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* PT/PTT normal
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No prior thromboembolic events or thrombophlebitis
* No prior recent myocardial infarction
* No prior angina
* No prior cerebrovascular accident
* No prior transient ischemic attacks
Other:
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* No grade 2 or greater sensory or motor neuropathy
* No active infection requiring antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered
Endocrine therapy:
* At least 1 week since prior hormonal therapy for endometrial carcinoma
* Concurrent hormone replacement therapy allowed
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered
Surgery:
* At least 3 weeks since prior surgery for endometrial carcinoma and recovered
* At least 6 months since prior re-vascularization procedures (e.g., coronary artery bypass graft, carotid endarterectomy or bypass, or angioplasty with or without stents)
Other:
* At least 3 weeks since other prior therapy for endometrial carcinoma
* At least 6 months since prior thrombolytic procedures
* No prior cyclin-dependent kinase inhibitors
* No prior anticancer therapy that would preclude study
* No concurrent amifostine or other protective reagents
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00023894
Study Brief:
Protocol Section:
NCT00023894