DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
This trial is active, not recruiting.
|Start date||April 2001|
|Trial identifier||NCT00024414, CDR0000068930, JHOC-01011003, PROTARGA-P01-00-04, THERADEX-P01-00-04|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Tucson, AZ||Arizona Oncology Associates||no longer recruiting|
|Berkeley, CA||Alta Bates Comprehensive Cancer Center||no longer recruiting|
|Lexington, KY||Lucille Parker Markey Cancer Center, University of Kentucky||no longer recruiting|
|Shreveport, LA||Louisiana State University Health Sciences Center - Shreveport||no longer recruiting|
|Baltimore, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||no longer recruiting|
|East Orange, NJ||Veterans Affairs Medical Center - East Orange||no longer recruiting|
|New York, NY||Herbert Irving Comprehensive Cancer Center||no longer recruiting|
|Philadelphia, PA||Kimmel Cancer Center of Thomas Jefferson University - Philadelphia||no longer recruiting|
Male participants at least 18 years old.
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
|Official title||Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer|
|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.|
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