Ixabepilone in Treating Patients With Metastatic, Recurrent, or Unresectable Kidney Cancer

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