Ixabepilone in Treating Patients With Metastatic Prostate Cancer

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00087139

Run by

National Cancer Institute (NCI)

People needed

124

Starts

2004-09-01

Expected to finish

2011-02-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Exempla Saint Joseph Hospital — Denver, Colorado, United States
• Presbyterian - Saint Lukes Medical Center - Health One — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• Colorado Cancer Research Program CCOP — Denver, Colorado, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Saint Mary's Hospital and Regional Medical Center — Grand Junction, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• Saint Anthony Hospital — Lakewood, Colorado, United States
• Sky Ridge Medical Center — Lone Tree, Colorado, United States
• Longmont United Hospital — Longmont, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• Saint Mary Corwin Medical Center — Pueblo, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• Exempla Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Nanticoke Memorial Hospital — Seaford, Delaware, United States
• Saint Francis Hospital - Wilmington — Wilmington, Delaware, United States
• Edna Williams Cancer Center at the Baptist Cancer Institute — Jacksonville, Florida, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Saint Joseph Medical Center — Bloomington, Illinois, United States
• Graham Hospital Association — Canton, Illinois, United States
• The Medical Center of Aurora — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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