Ixabepilone in Treating Patients With Metastatic Prostate Cancer | NCT00087139 | Trialant

Ixabepilone in Treating Patients With Metastatic Prostate Cancer | NCT00087139 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
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