Ixabepilone in Treating Patients With Metastatic Prostate Cancer
Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

About this trial
This is an interventional treatment trial for Adenocarcinoma of the Prostate
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
Sites / Locations
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Porter Adventist Hospital
- Exempla Saint Joseph Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Colorado Cancer Research Program CCOP
- Swedish Medical Center
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- McKee Medical Center
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Nanticoke Memorial Hospital
- Saint Francis Hospital - Wilmington
- Edna Williams Cancer Center at the Baptist Cancer Institute
- Lakeland Regional Cancer Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- Advocate Sherman Hospital
- Alexian Brothers Medical and Cancer Center
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare Galesburg
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Joliet Oncology-Hematology Associates Limited
- Kewanee Hospital
- Mcdonough District Hospital
- Garneau, Stewart C MD (UIA Investigator)
- Porubcin, Michael MD (UIA Investigator)
- Sharis, Christine M MD (UIA Investigator)
- Stoffel, Thomas J MD (UIA Investigator)
- Vigliotti, Antonio, P.G. M.D. (UIA Investigator)
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- Illinois Oncology Research Association CCOP
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Perry Memorial Hospital
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Clinic-Urbana Main
- Elkhart General Hospital
- Community Howard Regional Health
- Indiana University Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Saint Joseph Regional Medical Center-Mishawaka
- Saint Joseph Regional Medical Center - Mishawaka
- Memorial Hospital of South Bend
- South Bend Clinic
- Northern Indiana Cancer Research Consortium
- McFarland Clinic PC-William R Bliss Cancer Center
- Constantinou, Costas L MD (UIA Investigator)
- Saint Anthony Regional Hospital
- Saint Luke's Hospital
- Cedar Rapids Oncology Association
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Alegent Health Mercy Hospital
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa Oncology Research Association CCOP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Community Memorial Hospital
- Burgess Memorial Hospital
- Siouxland Regional Cancer Center
- Siouxland Hematology Oncology Associates
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Greater Baltimore Medical Center
- Eastern Cooperative Oncology Group
- Morton Hospital and Medical Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- Oakwood Hospital
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Kalamazoo Center for Medical Studies
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Lakeland Hospital
- Saint John Macomb-Oakland Hospital
- Essentia Health Duluth Clinic CCOP
- Essentia Health Saint Mary's Medical Center
- Miller-Dwan Hospital
- Meeker County Memorial Hospital
- Virginia Piper Cancer Institute
- Saint Joseph's Hospital - Healtheast
- Woodwinds Health Campus
- Fremont Area Medical Center
- Bryan LGH Medical Center West
- Bryan LGH Medical Center East
- Saint Elizabeth Regional Medical Center
- Midlands Community Hospital
- Ocean Medical Center
- Hunterdon Medical Center
- Cancer Institute of New Jersey At Hamilton
- Mountainside Hospital
- Morristown Memorial Hospital
- Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
- Cancer Institute of New Jersey
- Overlook Hospital
- Virtua West Jersey Hospital Voorhees
- Albert Einstein College of Medicine
- Montefiore Medical Center-Wakefield Campus
- Montefiore Medical Center
- Mary Imogene Bassett Hospital
- Mercy Medical Center
- MetroHealth Medical Center
- Lehigh Valley Hospital
- Saint Luke's University Hospital-Bethlehem Campus
- Bryn Mawr Hospital
- Penn State Milton S Hershey Medical Center
- Lewistown Hospital
- Paoli Memorial Hospital
- Mount Nittany Medical Center
- Lankenau Hospital
- Mainline Health CCOP
- Sanford Cancer Center-Oncology Clinic
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Sacred Heart Hospital
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- UW Cancer Center Johnson Creek
- Gundersen Lutheran
- UW Health Oncology - 1 South Park
- University of Wisconsin Hospital and Clinics
- Bay Area Medical Center
- Green Bay Oncology - Oconto Falls
- Marshfield Clinic-Rice Lake Center
- Green Bay Oncology - Sturgeon Bay
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients are stratified according to prior chemotherapy (none vs 1 prior taxane-containing regimen vs 2 prior cytotoxic regimens). Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.