Ixabepilone in Treating Patients With Metastatic Prostate Cancer
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: ixabepilone
Intervention description: Given IV
Intervention MeSH terms: Epothilones; Epothilone B
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells
      from dividing so they stop growing or die. This phase II trial is studying how well
      ixabepilone works in treating patients with metastatic prostate cancer that has not responded
      to previous hormone therapy.
    

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