NCT01705652终止2 期
Phase II Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients Undergoing Surgery or Radiation Therapy
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- PSA (Prostate Specific Antigen)
研究概览
简要总结
The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to <1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Have a histologic diagnosis of prostate cancer (in more than 1 core) with one of the following:
- •Gleason > 6,
- •Unilateral Gleason 6 in ≥ 3 cores,
- •bilateral Gleason 6,
- •PSA > 10.0 ng/ml.
- •Age ≥18 years.
- •Has an ECOG Performance Status 0-2 or Karnofsky 60-
- •Has the following laboratory values at study entry: absolute neutrophil count (ANC) ≥ 1,500 cells/μL; platelet count ≥ 100,000 cells/μL; hemoglobin ≥ 9 g/dL; total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ALT and AST ≤ 1.5 x institutional ULN if alkaline phosphatase is ≤ULN creatinine and BUN ≤ 1.5 x institutional upper limit of normal (ULN)
- •Signed informed consent
- •No new, undiagnosed bone pain or has a negative bone scan. (within 2 months of consent) If there is no bone pain, then a bone scan is not required.
排除标准
- •Has documented metastatic disease.
- •Has received a prior chemotherapy or androgen ablation.
- •Has received prior immunotherapy.
- •Has been previously treated with Strontium, Samarium, other systemic radioisotopes or radiation therapy.
- •Has diagnosis of congestive heart failure
- •Currently taking anticoagulation medications, i.e., coumadin or heparin. Over the counter aspirin and ibuprofen are allowed.
- •Is receiving any other investigational agents for cancer.
- •Has a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of prostate cancer.
- •Has a serious intercurrent illness with a life expectancy of less than 5 years.
- •Has a concomitant medical, psychological, or social circumstance, which would interfere with compliance with the protocol treatment and follow-up.
- •Use of any herbal or alternative regimens, which may have antineoplastic or hormonal activity (including but not limited to finasteride, dutasteride, Saw Palmetto, PC-SPES, shark cartilage, etc), is prohibited while receiving study treatment.
- •Clinical stage T3 or T4 and PSA >10 ng/ml and Gleason >
- •Patient is to receive adjuvant androgen ablation with the radiation.
- •EKG which shows a baseline QTc > 450 msec or ischemic changes. For ischemic changes, patient will be eligible if evaluated and cleared by internal medicine.
- •Previous history of drug-induced QTc prolongation and/or concurrent treatment with medications that are known to produce or are suspected of QT prolongation.
研究组 & 干预措施
Nexrutine Surgery Group
Experimental
Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
干预措施: Nexrutine (Drug)
Nexrutine Radiation Group
Experimental
Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
干预措施: Nexrutine (Drug)
结局指标
主要结局
PSA (Prostate Specific Antigen)
时间窗: 3 months post end of radiation treatment or surgery
PSA decline to \< 1.0 ng/ml at 3 months post end of radiation or surgery
次要结局
未报告次要终点
研究者
Gregory P. Swanson, MD
Clinical Professor
The University of Texas Health Science Center at San Antonio
研究点 (1)
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