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DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer

Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00024414
Enrollment
Unknown
Registered
2003-01-27
Start date
2001-04-30
Completion date
Unknown
Last updated
2008-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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

Theradex
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026