NCT00482274终止2 期
Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.
Secondary
- Determine the time to PSA recurrence in patients receiving this treatment.
- Determine the time to metastatic disease in patients receiving this treatment.
- Determine the time to androgen independent state in patients receiving this treatment.
- Determine the time to death from any cause in patients receiving this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Criteria for Patient eligibility
- •Inclusion criteria
- •Histologically confirmed adenocarcinoma of the prostate.
- •Prior primary therapy for prostate cancer, including radical prostatectomy, external beam radiation therapy, or brachytherapy.
- •Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if prior to 8 months.
- •Serum testosterone < 50 ng/ml.
- •No evidence of metastases on bone scan.
- •No evidence of metastases on CT scan of the abdomen and pelvis.
- •ECOG performance status <
- •Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥ 100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN.
- •Signed informed consent.
排除标准
- •A second active malignancy during the last 5 years, except adequately treated non-melanoma skin cancer.
- •Life expectancy < 3 months.
- •Grade 2 or higher peripheral neuropathy.
- •Prior investigational agent within the past 28 days.
- •Less than a 10% decrease (or continued rise) in PSA in response to initial androgen-deprivation therapy.
- •More than 12 months since initiation of androgen-deprivation therapy.
- •Prior docetaxel chemotherapy.
- •Patients recently (within 28 days) started on corticosteroids, with the exception of inhaled and topical steroids. Patients on stable doses of systemic corticosteroids will be eligible.
结局指标
主要结局
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
时间窗: While receiving study treatment (approximately 6 months)
Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
次要结局
- Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)(Average days to develop recurrence from treatment start date amount applicable participants)
- Time to Metastatic Disease(Measured at Time of documented metastases (no historical estimate is available))
- Time to Androgen Independent State(Measured at date of documented androgen independence (no estimate available))
- Time to Death From Any Cause(measured at date of death (no estimate available))
研究者
Tom Beer
Principal Investigator
OHSU Knight Cancer Institute
研究点 (2)
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