Clinical trial NCT00182702 (phase 2, status: completed)
Conditions: clear cell renal cell carcinoma, recurrent renal cell cancer, stage iii renal cell cancer, stage iv renal cell cancer
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8, C96.20, C96.29, D47.09, C96.20, C96.29, D47.09, C96.20, C96.29, D47.09
Drugs: ixabepilone
SMILES: [H][C@]12C[C@H](NC(=O)C[C@H](O)C(C)(C)C(=O)[C@H](C)[C@@H](O)[C@@H](C)CCC[C@@]1(C)O2)C(\C)=C\C1=CSC(C)=N1
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