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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT00005966
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven previously untreated metastatic or unresectable renal cell carcinoma
* Retroperitoneal lymph nodes that are unresectable or those that are not resected at the investigator's discretion are considered metastatic disease
* Prior nephrectomy allowed provided there is evidence of unresponsive metastatic disease after surgery or within one month prior to study enrollment
* Bidimensionally measurable disease
* Measurable disease must be outside any prior radiotherapy port
* No history of brain metastases unless surgically resected or treated with gamma knife radiotherapy and currently without radiologic evidence of CNS disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Hemoglobin at least 9 g/dL (transfusion allowed)
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 3 times upper limit of normal
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No myocardial infarction within the past 6 months
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use 2 effective methods of contraception (1 highly active method and 1 barrier method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No uncontrolled diabetes or any other concurrent illnesses that would increase risk
* No history of peripheral neuropathy
* No severe depression
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy (including adjuvant interferon alfa therapy), cellular therapy, or vaccine therapy for renal cell carcinoma
* No prior antiangiogenesis therapy for renal cell carcinoma
* Immunotherapy for prior malignancy allowed (except for interferon alfa therapy)
Chemotherapy:
* No prior chemotherapy for renal cell carcinoma
* Chemotherapy for prior malignancy allowed
Endocrine therapy:
* No prior hormonal therapy for renal cell carcinoma
Radiotherapy:
* See Disease Characteristics
* At least 2 weeks since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
Other:
* More than 7 days since prior IV antibiotics for infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005966
Study Brief:
Protocol Section:
NCT00005966