NCT00087165已完成2 期
A Phase II Study of GTI-2040 in Combination With Docetaxel and Prednisone in Hormone-Refractory Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- PSA response rate
研究概览
简要总结
RATIONALE: GTI-2040 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. GTI-2040 may help docetaxel kill more tumor cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving GTI-2040 together with docetaxel and prednisone works in treating patients with prostate cancer that has not responded to hormone therapy.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of GTI-2040, docetaxel, and prednisone, in terms of prostate-specific antigen (PSA) response rate, in patients with hormone-refractory prostate cancer.
Secondary
- Determine objective tumor response in patients treated with this regimen.
- Determine the median time to progression in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the median duration of PSA response in patients treated with this regimen.
- Correlate baseline and post-treatment levels of ribonucleotide reductase activity in tumor biopsies and peripheral blood mononuclear cells and tumoral expression of c-myc, R2 subunit protein, and markers of cellular proliferation and apoptosis with clinical outcomes in patients treated with this regimen.
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 1 of the following:
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Metastatic carcinoma of presumptive prostate origin
- •Bony metastases AND a serum prostate-specific antigen (PSA) level > 20 ng/mL
- •Disease progression after prior hormonal therapy as defined by rising PSA levels
- •At least 2 consecutive rises in PSA over a reference value, with measurements taken at least 7 days apart
- •Prior hormonal therapy must include either medical (luteinizing hormone-releasing hormone [LHRH] agonist) OR surgical (orchiectomy) castration
- •Patients who received prior LHRH agonist must continue or re-start such therapy
- •Castrate levels of testosterone < 50 ng/dL
- •PSA ≥ 20 ng/mL
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •WBC ≥ 3,000/mm^3
- •AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin normal
- •PTT ≤ 1.25 times upper limit of control
- •INR ≤ 1.3
- •Creatinine ≤ 1.5 times ULN OR
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Fertile patients must use effective contraception
- •No symptomatic peripheral neuropathy ≥ grade 2
- •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to GTI-2040 or other study agents
- •No concurrent uncontrolled illness
- •No active or ongoing infection
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent prophylactic filgrastim (G-CSF) or epoetin alfa
- •Chemotherapy
- •No prior chemotherapy except monotherapy with oral estramustine
- •At least 4 weeks since prior estramustine and recovered
- •Endocrine therapy
- •See Disease Characteristics
- •At least 6 weeks since prior bicalutamide*
- •At least 4 weeks since prior flutamide, nilutamide, or cyproterone*
- •Concurrent steroids allowed NOTE: *Patients must have evidence of disease progression despite cessation of antiandrogen therapy
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
PSA response rate
次要结局
- Median survival
- 1-year survival
- Response rate and duration
研究者
研究点 (5)
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