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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT00405366
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of renal cell carcinoma (RCC) as confirmed by either of the following:
* Radiographic documentation by MRI or CT scan
* Histological evidence of primary RCC
* Stage II-IV disease, as defined by any of the following:
* T \> 7 cm
* Renal vein involvement
* Local invasion
* Evidence of lymph node involvement
* Distant metastatic disease
* Deemed suitable for nephrectomy by a urologist
* No requirement for surgery earlier than 4 weeks from study entry
* No known brain metastasis
* Patients with neurological symptoms must undergo a CT scan or brain MRI to exclude brain metastasis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Hemoglobin ≥ 9.0 g/dL
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for patients with liver involvement)
* Creatinine ≤ 2.5 times ULN or glomerular filtration rate ≥ 50 mL/min
* INR ≤ 1.5 AND PTT normal
* Stable INR required at baseline for patients on warfarin
* Not pregnant or nursing
* Negative pregnancy test
* Fertile women must use effective contraception
* Fertile men must use effective contraception during and for ≥ 2 months after the last dose of sorafenib tosylate
* No other active primary malignancy except skin cancer
* No active coronary artery disease
* No active bleeding diathesis
* Closely monitored therapeutic anticoagulation allowed
* No cardiac disease, including any of the following:
* New York Heart Association class III-IV congestive heart failure
* Unstable angina (i.e., anginal symptoms at rest) or new onset angina (i.e., beginning within the past 3 months)
* Myocardial infarction within the past 6 months
* No cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* No uncontrolled hypertension, defined as systolic blood pressure (BP) \> 150 mm Hg or diastolic BP \> 90 mm Hg, despite optimal medical management
* No known HIV infection or chronic hepatitis B or C
* No active, clinically serious infection \> grade 2
* No thrombolic or embolic events, such as a cerebrovascular accident or transient ischemic attacks, within the past 6 months
* No pulmonary hemorrhage or bleeding event ≥ grade 2 within the past 4 weeks (≥ grade 3 for any nonpulmonary hemorrhage or bleeding event)
* No serious nonhealing wound, ulcer, or bone fracture
* No significant traumatic injury within the past 4 weeks
* No known or suspected allergy to sorafenib tosylate or any agent given in the course of this study
* No condition that impairs the patient's ability to swallow whole pills
* No malabsorption problem
PRIOR CONCURRENT THERAPY:
* No major surgery or open biopsy within the past 4 weeks
* Concurrent anticoagulation therapy (e.g., warfarin or heparin) allowed
* No other concurrent investigational or commercial agents or therapies for RCC
* No concurrent Hypericum perforatum (St. John's wort) or rifampin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00405366
Study Brief:
Protocol Section:
NCT00405366