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 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT00003968
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic renal cell carcinoma
* Bidimensionally measurable disease
* Clear evidence of progression if only site of measurable disease is within previous radiation port
* Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids
PATIENT CHARACTERISTICS:
* Age: 18 and over
* Performance status: ECOG 0-1
* Life expectancy: Greater than 3 months
* WBC at least 3,000/mm3
* Platelet count at least 100,00/mm3
* Bilirubin no greater than 1.5 mg/dL
* Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study
* No active bacterial or viral infection
* No serious underlying medical condition that would interfere with compliance
* No other malignancy within the past 5 years except basal cell carcinoma of the skin
* No dementia or altered mental status that would prevent informed consent
PRIOR CONCURRENT THERAPY:
* No more than 1 prior therapy with biologic response modifiers
* No prior chemotherapy for advanced disease
* No other concurrent chemotherapy
* No concurrent steriods (except topical use)
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
* At least 4 weeks since major surgery (including nephrectomy)
* No other concurrent experimental agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003968
Study Brief:
Protocol Section:
NCT00003968