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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT00182702
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed renal cell carcinoma of 1 of the following subtypes:
* Clear cell
* Papillary, type I or II
* Chromophobe
* Collecting duct
* Medullary
* Metastatic, recurrent, or unresectable disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No known active brain metastases requiring steroid or anticonvulsant therapy
* Patients with definitively treated brain metastases are eligible provided they are not on steroids or anticonvulsants AND show no evidence of disease progression for ≥ 3 months after completion of definitive therapy
* Performance status - ECOG 0-2
* At least 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Glomerular filtration rate ≥ 50 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing or active infection
* No HIV positivity
* No peripheral neuropathy \> grade 1
* No psychiatric illness or social situation that would preclude study compliance
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug
* No history of severe hypersensitivity reaction to agents containing Cremophor® EL
* No other active malignancy
* Curatively treated malignancies are allowed provided the risk of recurrent disease at the time of study enrollment is \< 20%
* No other uncontrolled illness
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No prior tubule inhibitors, including, but not limited to, any of the following:
* Vinca alkaloids (e.g., vinblastine, vincristine, or vinorelbine)
* Taxanes (e.g., docetaxel or paclitaxel)
* Epothilones
* No other concurrent chemotherapy
* See Disease Characteristics
* No concurrent hormonal therapy except steroids for adrenal failure or hypersensitivity prophylaxis or hormones for non-disease related conditions (e.g., insulin for diabetes)
* More than 4 weeks since prior radiotherapy and recovered
* No concurrent palliative radiotherapy
* No other concurrent investigational agents
* No other concurrent anticancer therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00182702
Study Brief:
Protocol Section:
NCT00182702