This trial is active, not recruiting.

Condition prostate cancer
Treatment dha-paclitaxel
Phase phase 2
Sponsor Theradex
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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).