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 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT00085332
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed endometrial carcinoma
* Recurrent or persistent disease
* Refractory to curative or standard therapy
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* At least 1 target lesion
* Tumors within a previously irradiated field are not considered target lesions
* Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
* One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
* Ineligible for a higher priority GOG protocol
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* GOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* SGOT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No neuropathy (sensory and motor) ≥ grade 2
* No active infection requiring antibiotics
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 3 weeks since prior biologic or immunologic therapy for malignant tumor
* No concurrent prophylactic growth factors
* No concurrent prophylactic thrombopoietic agents
Chemotherapy
* See Disease Characteristics
* Recovered from prior chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)
Endocrine therapy
* At least 1 week since prior hormonal therapy for malignant tumor
* Concurrent hormone replacement therapy allowed
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
Surgery
* Recovered from prior surgery
Other
* At least 3 weeks since other prior therapy for malignant tumor
* No prior anticancer therapy that would preclude current protocol therapy
* No concurrent amifostine or other protective reagents
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00085332
Study Brief:
Protocol Section:
NCT00085332