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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00003969
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven malignancies refractory to conventional treatment or for which no standard therapy exists
* Primary brain tumor or brain metastases allowed if stable symptoms within 2 weeks prior to study and able to give informed consent
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Performance status:
* WHO 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10.0 g/dL
* Absolute neutrophil count at least 1,500/mm\^3
Hepatic:
* Bilirubin less than 1.0 mg/dL
* AST and ALT no greater than 2.5 times upper limit of normal if due to liver metastases
* No chronic liver disease
Renal:
* Creatinine less than 1.47 mg/dL OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* No myocardial infarction within the past 6 months
* No angina requiring treatment within the past 6 months
* No uncompensated coronary artery disease by electrocardiogram or physical examination
* No prior transient ischemic attacks, stroke, or peripheral vascular disease
* LVEF at least 45%
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after study
* No allergy to egg products
* No nonmalignant systemic disease that would increase risk
* No active uncontrolled infection
* No diabetes mellitus with evidence of severe peripheral vascular disease or diabetic ulcers
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered
* No other concurrent chemotherapy
Endocrine therapy:
* At least 4 weeks since other prior endocrine therapy and recovered
* Concurrent corticosteroids for symptom control allowed if no change in dose requirement within 2 weeks prior to study
Radiotherapy:
* At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
* Concurrent radiotherapy allowed for control of bone pain or as indicated
Surgery:
* Not specified
Other:
* No other concurrent investigational treatment
* No concurrent treatment with drugs interfering with hepatic CYP3A4 metabolism (e.g., grapefruit juice or warfarin)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00003969
Study Brief:
Protocol Section:
NCT00003969