NCT00054574已完成2 期
A Clinical Trial Evaluating The Safety And Efficacy Of ABX-EGF In Patients With Hormone Resistant Prostate Cancer With Elevated PSA Without Metastasis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
- Determine the clinical effect of monoclonal antibody ABX-EGF, determined by the PSA response, in patients with hormone-resistant prostate cancer with rising PSA values without metastasis.
- Determine the pharmacokinetics and safety profile (including immunogenicity) of this drug in these patients.
- Determine the overall survival of patients treated with this drug.
- Determine the time to disease progression and time to PSA progression in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly. Treatment continues every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of prostate cancer with rising PSA values without metastasis
- •PSA must be at least 5 ng/mL
- •PSA must show an increase above a reference level on 2 separate occasions
- •Must have tumor over-expressing epidermal growth factor receptor (EGFr) by immunohistochemistry
- •Staining must be 2+ or 3+ in at least 10% of evaluated tumor cells
- •Must have tissue available for diagnostics
- •Must have failed prior front-line luteinizing hormone-releasing hormone (LHRH) analogue (e.g., leuprolide or goserelin) OR failed orchiectomy and have castrate levels of testosterone (less than 50 mg/mL) NOTE: Must continue on a LHRH analogue (unless an orchiectomy was performed) throughout the study
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count greater than 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 3 times ULN
- •AST and ALT no greater than 3 times ULN
- •Creatinine less then 2.2 mg/dL
- •Calcium no greater than ULN
- •Cardiovascular
- •Left ventricular ejection fraction at least 45% by MUGA
- •No myocardial infarction within the past year
- •HIV negative
- •Fertile patients must use effective contraception during and for 1 month after study
- •No other malignancy within the past 5 years except basal cell carcinoma
- •No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation, administration, or interpretation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •See Disease Characteristics
- •At least 6 weeks since prior steroidal or nonsteroidal antiandrogens (4 weeks for flutamide)
- •Concurrent steroid therapy allowed as replacement therapy only
- •Radiotherapy
- •Not specified
- •See Disease Characteristics
- •At least 30 days since prior investigational therapy
- •At least 30 days since prior anticancer therapy
- •No prior systemic therapy for prostate cancer (except hormonal therapy)
- •No prior anti-EGFr therapy
- •Concurrent antihypercalcemic treatment allowed in the presence of elevated calcium levels but not as cancer therapy for bone disease
- •No other concurrent anti-EGFr therapy
- •No other concurrent anticancer therapy
- •No other concurrent investigational therapy
排除标准
- 未提供
研究者
研究点 (2)
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