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:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT00747305
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of clear cell renal cell carcinoma
* Metastatic disease
* Primary tumor is considered amenable to surgery
* Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as \> 20 mm by conventional techniques or as \> 10 mm by spiral CT scan
* No untreated brain metastases
* Treated brain metastases allowed provided lesion has been stable on two consecutive CT or MRI scans separated by ≥ 2 months
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Leukocytes ≥ 3,000/μL
* ANC ≥ 1,500/μL
* Platelet count ≥ 75,000/μL
* Hemoglobin ≥ 8.5 g/dL
* Total Bilirubin ≤ 2 times upper limits of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to undergo nephrectomy and treatment with sunitinib malate
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
* No prior systemic treatment with sunitinib malate
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* Concurrent medications or substances known to affect, or with the potential to affect, the activity or pharmacokinetics of sunitinib malate allowed at the discretion of the principal investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00747305
Study Brief:
Protocol Section:
NCT00747305