NCT00085228已完成2 期
Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer
European Organisation for Research and Treatment of Cancer - EORTC32 个研究点 分布在 11 个国家目标入组 116 人开始时间: 2004年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 32
- 主要终点
- Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.
详细描述
OBJECTIVES:
Primary
- Compare the activity of docetaxel with or without oblimersen, in terms of prostate-specific antigen response, in patients with hormone-refractory adenocarcinoma of the prostate.
- Compare the toxicity of these regimens in these patients.
Secondary
- Compare the time to progression in patients treated with these regimens.
- Compare survival of patients treated with these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Hormone-refractory disease
- •Disease progression after prior hormonal therapy with luteinizing hormone-releasing hormone (LH-RH) analogues or orchiectomy and antiandrogens (given together or consecutively)
- •Prostate-specific antigen (PSA) progression documented by at least 2 increases in PSA values over previous PSA reference value
- •Must demonstrate continued PSA elevation for at least 6 weeks after discontinuation of antiandrogen therapy
- •PSA ≥ 5 ng/mL (Hybritech or equivalent) within the past week
- •Testosterone ≤ 0.5 ng/mL* NOTE: *Patients with medical castration with LH-RH analogue must continue with LH-RH analogue throughout the study
- •No evidence of painful and/or destructive bone metastases requiring concurrent radiotherapy, bisphosphonates, or bone-seeking radionuclides
- •Other bone metastases allowed
- •No clinical evidence of brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,500/mm^3
- •Hemoglobin ≥ 10 g/dL
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin ≤ ULN
- •PTT and PT ≤ 1.5 times ULN OR
- •INR ≤ 1.3
- •Creatinine ≤ 1.5 times ULN OR
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No unstable angina
- •No uncontrolled hypertension
- •No deep venous thrombosis within the past 6 months
- •No cerebrovascular accident, transient ischemic attack, or myocardial infarction within the past 6 months
- •No pulmonary embolism
- •No history of interstitial pneumonitis
- •No history of pulmonary fibrosis
- •Adequate venous access
- •HIV negative
- •No active infection
- •No pre-existing neuropathy
- •No hypersensitivity to phosphorothioates
- •No hypersensitivity to oligonucleotides or any other component of the oblimersen formulation or to drugs formulated with polysorbate
- •No psychological, familial, sociological, or geographical condition that would preclude study compliance
- •No other malignancy within the past 5 years except adequately treated superficial urothelial or skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Prior estramustine allowed
- •No other prior chemotherapy
- •No concurrent estramustine
- 另有 18 项未显示
排除标准
- 未提供
结局指标
主要结局
Prostate-specific antigen response as measured by Bubley criteria every course until progression or after 12 courses
Severe toxic events as measured by CTCAE v3.0 every course until progression or after 12 courses
次要结局
- Time to progression as measured by RECIST and Bubley criteria every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- Toxicity as measured by CTCAE v3.0 every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- Objective response as measured by RECIST every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
- Overall survival as measured by Logrank every 3 courses, and then every 8 weeks until progression, and every 16 weeks from progression until death
研究者
研究点 (32)
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