Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT)
研究概览
简要总结
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
详细描述
The Study Drugs:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.
Luteinizing Hormone-Releasing Hormone (LHRH) Analogues like Lupron® (leuprolide) and Zoladex® (goserelin) are hormonal treatments used to help stop the body from making testosterone (male sex hormones) in the body. Prostate cancer cells need testosterone to survive.
Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male hormones like testosterone.
Study Drug Administration:
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
- •Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA > 20ng/ml.
- •Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3, Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x upper normal limit (UNL), Total bilirubin within normal limits (WNL).
- •No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
- •Patients must be at least 18 years of age
- •Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.
排除标准
- •Prior VEGFR/PDGFR inhibitor or other investigational therapy.
- •Inability to take oral medication
- •Chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.
- •Left Ventricular Ejection Fraction </= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
- •Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
研究组 & 干预措施
Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
干预措施: Leuprolide (Drug)
Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
干预措施: Goserelin (Drug)
Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
干预措施: Sunitinib Malate (Drug)
Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
干预措施: Casodex (Drug)
Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
干预措施: Radiation Therapy (RT) (Radiation)
结局指标
主要结局
Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT)
时间窗: 8 weeks
DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If \< 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been treated with 2 or less than 2 instances of DLT. DLT for the purposes of dose-escalation or calculation of the maximum tolerated dose (MTD) defined as any medically unmanageable Grade 2 toxicity or any Grade 3 or 4 toxicity experienced during the 8 week period of combined hormone ablation, Sunitinib, and radiation therapy.
次要结局
未报告次要终点