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:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT00003928
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven metastatic renal cell carcinoma
* No brain metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,500/mm\^3
* Hematocrit at least 30%
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* AST and ALT no greater than 1.5 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No uncontrolled hypertension
* No myocardial infarction within the past 8 weeks
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy within the past 5 years except nonmelanomatous skin cancer, carcinoma in situ of cervix, prostate intraepithelial neoplasia, or superficial bladder cancer
* No significant psychiatric disease
* No active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No more than 2 prior biologic response modifier regimens
* No concurrent biologic therapy
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior radiotherapy allowed if measurable disease is outside radiation port
* At least 28 days since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* Prior surgery allowed
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003928
Study Brief:
Protocol Section:
NCT00003928