NCT00071968已完成2 期
An Open-Label Study Of Exploratory Pharmacogenomics And Pharmacologic Effects Of Neoadjuvant Oral CCI-779 In Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have A High Risk Of Relapse
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Phosphorylation state of proteins
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving CCI-779 before surgery may shrink the tumor so that it can be removed.
PURPOSE: This randomized phase II trial is studying how well CCI-779 works in treating patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high risk of relapse.
详细描述
OBJECTIVES:
Primary
- Determine the effects of oral CCI-779 on changes in the phosphorylation state of proteins in the mammalian target of rapamycin (mTOR) signaling pathway in the tumor tissue of patients with newly diagnosed prostate cancer undergoing radical prostatectomy.
- Determine the effects of this drug on changes in p70S6 kinase activity, phosphorylation state of mTOR pathway proteins, and on global and targeted gene expression patterns in the peripheral blood mononuclear cells (PBMCs) of these patients.
Secondary
- Determine the effects of this drug on global and targeted gene expression patterns in these patients.
- Identify pharmacodynamic/pharmacogenomic surrogate markers of this drug in both tumor tissue and PBMCs and determine if blood may be used as a surrogate tissue source for biomarkers of drug activity in the tumor in these patients.
- Determine, preliminarily, the potential antitumor effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate phosphatase and tensin homolog (PTEN) gene status with the pharmacodynamic/pharmacogenomic effects of this drug in these patients.
- Determine the effects of this drug on changes in protein expression patterns in the plasma of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Diagnosis based on a minimum of 6 core biopsy samples
- •Clinically confirmed organ-confined disease
- •Candidate for radical prostatectomy
- •No evidence of metastatic disease by CT scan and bone scan
- •High risk of relapse based on either of the following criteria:
- •Any one of the following:
- •Stage T2C or higher
- •Gleason score greater than 7
- •Prostate-specific antigen (PSA) greater than 20 ng/mL OR
- •Any two of the following:
- •Gleason score at least 7
- •PSA 10-20 ng/mL
- •Greater than 50% of total biopsy cores with cancer involvement
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No active bleeding
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •No acute or chronic hepatitis B
- •Hepatitis B surface antigen negative
- •No acute or chronic hepatitis C
- •No antibodies to hepatitis C
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •AST and ALT no greater than 2 times ULN
- •No ongoing urinary tract infection necessitating rapid or emergent surgical resection
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular
- •No unstable angina
- •No myocardial infarction within the past 6 months
- •No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy
- •No known pulmonary hypertension
- •No pneumonitis
- •Fertile patients must use effective contraception during and for 12 weeks after study participation
- •HIV negative
- •No other severe immunocompromised states
- •No active infection requiring antibiotic therapy
- •No serious concurrent illness
- •No other major illness that would substantially increase the risk associated with study participation
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- 另有 16 项未显示
排除标准
- 未提供
结局指标
主要结局
Phosphorylation state of proteins
p70S6 kinase activity
Phosphorylation state of mTOR pathway proteins
Global and targeted gene expression patterns in peripheral blood mononuclear cells
次要结局
- Protein expression patterns in the plasma
- Global and targeted gene expression patterns
- Pharmacodynamics and pharmacogenomic surrogate markers
- Antitumor effects
- Pharmacokinetics
- Correlation of phosphatase and tensin homolog gene status with pharmacodynamic and pharmacogenomic effects
研究者
研究点 (2)
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