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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT00003135
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma
* Measurable and evaluable disease
* No brain metastases
* No hepatic involvement greater than 80%
* No lung involvement greater than 30%
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Not specified
Menopausal status:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute granulocyte count greater than 1,500/mm\^3
* Platelet count greater than 90,000/mm\^3
* Normal bone marrow cellularity on bone marrow biopsy
* Thrombin time less than 17 sec
* Fibrinogen greater than 200 mg/dL
* FSP less than 40
* No coagulopathy
Hepatic:
* Bilirubin less than 2.0 mg/dL
* SGPT less than 2 times normal
* PT less than 14 sec
* PTT less than 35 sec
Renal:
* BUN less than 25 mg/dL
* Creatinine clearance at least 45 mL/min
Cardiovascular:
* Normal cardiovascular system
* Resting ventricular ejection fraction greater than 40%
* No prior myocardial infarction
* No symptomatic coronary artery disease
* No unstable blood pressure
* No thromboembolic disease
Neurologic:
* No seizures or other CNS disorders
* Negative computerized tomographic scan of brain
Pulmonary:
* FEV\_1 greater than 70% of predicted
* Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values
* No history of cardiopulmonary or respiratory disease
Other:
* No other serious concurrent medical illness
* No diabetes mellitus
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior chemotherapy allowed
Endocrine therapy:
* No adrenal corticosteroids
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent cardiac glycosides, antianginal therapy, or antiarrhythmics
* No concurrent vasodilators, anticoagulants, thrombolytic agents, or aspirin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00003135
Study Brief:
Protocol Section:
NCT00003135