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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00058318
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed renal cell carcinoma
* Metastatic (M1) disease OR
* M0 provided the primary tumor is unresectable
* Measurable disease
* At least 1 unidimensionally measurable lesion
* Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
* Soft tissue disease within a prior radiation field is measurable provided it has progressed since therapy and there is also measurable disease outside of the irradiated field
* No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (SGOT) no greater than 1.5 times ULN
Renal
* Creatinine clearance at least 50 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other concurrent uncontrolled illness that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
* No uncontrolled diabetes mellitus
* No ongoing or active infection
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No more than 2 prior immunotherapy regimens comprising interferon (IFN) and/or interleukin-2 (IL-2)
* At least 28 days since prior IFN or IL-2 and recovered
Chemotherapy
* No prior chemotherapy for renal cell cancer
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy to 25% or more of the bone marrow
* At least 21 days since prior radiotherapy and recovered
Surgery
* At least 28 days since prior surgery and recovered
* Prior resection of the primary tumor allowed (in patients with metastatic disease)
Other
* At least 4 weeks since prior sorivudine or brivudine
* No concurrent sorivudine or chemically related analogues (e.g., brivudine)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00058318
Study Brief:
Protocol Section:
NCT00058318