dha-paclitaxel in treating patients with metastatic prostate cancer

Conditions: Prostate Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dha-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

objectives: * determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with dha-paclitaxel. * determine the overall survival of patients treated with this drug. * determine the toxicity profile of this drug in these patients. * assess the quality of life of patients treated with this drug. outline: this is a multicenter study. patients receive dha-paclitaxel iv over 2 hours on day 1. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, every 2 courses, and off study. patients are followed every 3 months. projected accrual: a total of 18-50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the prostate * progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (lhrh) agonist) * progressive disease is defined by all of the following: * measurable disease or lesions on bone scan * increases in prostate-specific antigen (psa) levels on at least 2 consecutive measurements * continued psa elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide) * psa level at least 5 ng/ml * serum testosterone level less than 50 ng/ml * patients who have not undergone prior surgical castration should continue primary androgen suppression (lhrh agonist) * no known or clinical evidence of cns metastasis patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * sgot or sgpt no greater than 2.5 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular: * no uncontrolled ventricular arrhythmia * no myocardial infarction within the past 3 months * no superior vena cava syndrome neurologic: * no peripheral neuropathy greater than grade 1 * no uncontrolled major seizure disorder * no spinal cord compression other: * no psychiatric disorder that would preclude informed consent * no unstable or serious concurrent medical condition * no concurrent serious infection requiring parenteral therapy * no other prior or concurrent malignancy except: * curatively treated nonmelanoma skin cancer or * other cancer curatively treated with surgery alone that has not recurred for more than 5 years * fertile patients must use effective contraception during and for at least 6 months after study therapy prior concurrent therapy: biologic therapy: * no concurrent immunotherapy chemotherapy: * no prior taxanes * prior mitoxantrone or prednisone for metastatic disease allowed * at least 28 days since prior chemotherapy and recovered * no other concurrent chemotherapy endocrine therapy: * see disease characteristics * no concurrent hormonal therapy radiotherapy: * no prior samarium sm 153 lexidronam pentasodium or strontium chloride sr 89 * prior external radiotherapy for metastatic disease allowed * at least 28 days since prior large-field radiotherapy and recovered * no concurrent radiotherapy, including whole-brain radiotherapy for documented cns metastasis surgery: * see disease characteristics * at least 14 days since prior major surgery and recovered other: * no other prior nonhormonal treatment for metastatic disease * at least 28 days since prior herbal preparations (e.g., pc-spes) and recovered * no other concurrent anticancer medications

Keywords: adenocarcinoma of the prostate stage iv prostate cancer recurrent prostate cancer