Clinical trial NCT00087139 (phase 2, status: completed)
Conditions: adenocarcinoma of the prostate, recurrent prostate cancer, stage iv prostate cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
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 confirmed adenocarcinoma of the prostate

          -  Metastatic disease

          -  Evidence of disease progression (e.g., new lesions on bone scan or new/enlarging
             lesions on CT scan) OR rising prostate-specific antigen (PSA) within the past 4 weeks

          -  Radiologic evidence of hydronephrosis alone is not considered evidence of metastatic
             disease (e.g., increasing PSA)

          -  Patients with bone metastases only (i.e., lacking soft tissue disease) must have a PSA
             level >= 10 ng/mL within the past week

          -  Patients with stable disease and rising PSA must show 2 consecutive rises in PSA
             measurements taken at least 2 weeks apart

          -  Most recent PSA level must be obtained within the past 4 weeks

          -  Disease progression after prior anti-androgen withdrawal must be confirmed by a rising
             PSA after the 4-6 week washout period (e.g., PSA level higher than the last PSA
             obtained while on anti-androgen therapy)

          -  Failed prior bilateral orchiectomy or other primary hormonal therapy

          -  Patients who have not undergone bilateral orchiectomy must continue on luteinizing
             hormone-releasing hormone (LHRH) agonist therapy (e.g., leuprolide or goserelin) or
             LHRH antagonist (e.g., abarelix) during study treatment AND must have a serum
             testosterone level =< 50 ng/dL within the past 4 weeks to confirm androgen suppression

          -  ECOG 0-2

          -  Granulocyte count >= 1,500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  WBC >= 4,000/mm^3

          -  SGPT =< 2 times upper limit of normal

          -  Bilirubin =< 1.5 mg/dL

          -  INR normal

          -  Creatinine =< 1.5 mg/dL

          -  Creatinine clearance >= 50 mL/min

          -  No New York Heart Association class III-IV heart disease

          -  No myocardial infarction within the past 6 months

          -  No active angina pectoris

          -  No evidence of ventricular dysrhythmias or other unstable arrhythmia

          -  Rate-controlled atrial fibrillation allowed provided the patient is asymptomatic

          -  No other malignancy within the past 5 years except curatively treated nonmelanoma skin
             cancer

          -  No serious medical illness or active infection that would preclude study participation

          -  No concurrent prophylactic filgrastim (G-CSF)

          -  No more than 2 prior cytotoxic chemotherapy regimens for hormone-refractory disease

          -  At least 4 weeks since prior chemotherapy with a taxane-based regimen, mixantrone, or
             another cytotoxic chemotherapy regimen provided there is evidence of progressive
             disease

          -  At least 4 weeks since prior flutamide AND continued evidence of progressive disease

          -  At least 6 weeks since prior bicalutamide or nilutamide AND continued evidence of
             progressive disease

          -  At least 4 weeks since prior estrogen or estrogen-like agents (e.g., PC-SPES, saw
             palmetto, or other herbal products which may contain phytoestrogens)

          -  At least 4 weeks since prior hormonal therapy, including megestrol, finasteride,
             ketoconazole, or systemic corticosteroids

          -  No concurrent estrogen or estrogen-like agents (e.g., PC-SPES, saw palmetto, or other
             herbal products which may contain phytoestrogens)

          -  More than 4 weeks since prior radiotherapy

          -  No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium

          -  No other prior radioisotope

          -  No concurrent radiotherapy for pain control

          -  No more than 1 prior experimental (non-cytotoxic) therapy AND evidence of progressive
             disease

          -  At least 4 weeks since prior experimental therapy

          -  Concurrent bisphosphonates (e.g., pamidronate or zoledronate) allowed provided
             treatment was initiated at least 4 weeks ago and there is evidence of progressive
             disease

          -  No other concurrent investigational agents

          -  No concurrent therapeutic warfarin

          -  Concurrent prophylactic or therapeutic doses of low molecular weight heparin allowed
             provided criterion for INR is met

          -  No carcinomatous meningitis or brain metastases

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy > grade 1