Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States