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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00022620
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed endometrial papillary carcinoma (uterine papillary serous carcinoma)
* Progressive or recurrent
* Bidimensionally measurable disease
* Platinum refractory disease, defined by one of the following:
* Progression during platinum-based chemotherapy
* Stable disease for at least 4 courses of platinum-based chemotherapy
* Recurrence within 4 months of platinum-based chemotherapy
* No brain involvement or leptomeningeal disease
PATIENT CHARACTERISTICS:
Age:
* 75 and under
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 50 umol/L
Renal:
* BUN no greater than 8.0 mmol/L
* Creatinine no greater than 120 umol/L
* Creatinine clearance at least 60 mL/min
Other:
* Not pregnant
* Fertile patients must use effective contraception
* HIV negative
* No other prior or concurrent malignancy except basal cell carcinoma of the skin
* No active bacterial infection (e.g., urinary tract infection)
* No uncontrolled or potentially active site of infection (e.g., fistula or abscess)
* No psychological, familial, sociological, or geographical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* At least 1 prior platinum containing regimen
* At least 50 mg/m2 per course for a maximum of 28 days for cisplatin
* At least 5 times AUC for a maximum of 4 weeks per course for carboplatin
* Prior non-taxane-containing chemotherapy allowed
Endocrine therapy:
* At least 4 weeks since prior hormonal therapy
Radiotherapy:
* At least 4 weeks since prior radiotherapy
* At least 3 months since prior radiotherapy to target lesion
* Concurrent radiotherapy allowed for bone pain provided evaluable lesions are outside of irradiation field)
Surgery:
* Prior surgical management of lymph nodes allowed
Healthy Volunteers:
False
Sex:
FEMALE
Maximum Age:
75 Years
Study:
NCT00022620
Study Brief:
Protocol Section:
NCT00022620