Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer
Clear Cell Renal Cell Carcinoma, Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer
About this trial
This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma
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
Sites / Locations
- University of Chicago Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.