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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00089102
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed renal cell carcinoma
* Locally advanced unresectable or metastatic disease
* Unidimensionally measurable disease by physical exam or imaging study
* The following are not considered measurable disease:
* Bone only disease
* Pleural or peritoneal effusions
* CNS lesions
* Irradiated lesions unless disease progression was documented after radiotherapy
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* ALT and AST \< 3 times upper limit of normal
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine ≤ 2.0 mg/dL
Gastrointestinal
* No active inflammatory bowel disease
* No significant bowel obstruction
* No chronic diarrhea
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No mental incapacitation or psychiatric illness that would preclude giving informed consent
* No other active malignancy except nonmelanoma skin cancer
* No other severe disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 4 weeks since prior immunotherapy
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent palliative radiotherapy
Surgery
* Not specified
Other
* No concurrent participation in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00089102
Study Brief:
Protocol Section:
NCT00089102