A Phase 2 Study of Capecitabine, Temozolomide, and Bevacizumab for Metastatic or Unresectable Pancreatic Neuroendocrine Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Radiographic Response (RR)
研究概览
简要总结
The purpose of this research is to evaluate the effectiveness and safety of a combination of capecitabine, temozolomide and bevacizumab in the treatment of advanced pancreatic neuroendocrine tumors.
详细描述
PRIMARY OBJECTIVES:
- Estimate if the combination of capecitabine and temozolomide with bevacizumab for metastatic or unresectable neuroendocrine tumors will improve response rate (RR) by 62% over historical controls (null RR of 40% to true RR 65%).
- Assess the toxicities using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
SECONDARY OBJECTIVES:
- Evaluate progression-free survival (PFS) and overall survival (OS) using Kaplan-Meier analysis.
- Assess O6-methyl guanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) at baseline by central pathology (path) review.
- Assess serum hormone marker levels.
- Evaluate computed tomography (CT) Perfusion as a tool to predict early therapeutic response. (Optional)
- Bank serum for future correlative analyses.
OUTLINE:
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bevacizumab + Capecitabine + Temozolomide
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Bevacizumab (Biological)
Bevacizumab + Capecitabine + Temozolomide
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Capecitabine (Drug)
Bevacizumab + Capecitabine + Temozolomide
Cycles repeat every 28 days until disease progression, unacceptable toxicity, or withdrawal.
干预措施: Temozolomide (Drug)
结局指标
主要结局
Radiographic Response (RR)
时间窗: 18 months
Tumor response to treatment with the combination of capecitabine \& temozolomide plus bevacizumab in patients with metastatic or unresectable pancreatic neuroendocrine tumors was assessed per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) for target lesions. Response is defined as: * Complete Response (CR) = Disappearance of all target lesions * Partial Response (PR) = ≥ 30% decrease in the sum of the longest diameter of target lesions * Overall Response (OR) = CR + PR * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s) * Stable disease (SD) = Small changes that do not meet any of the above criteria The outcome is reported as the number of participants who between 3 and 18 months after treatment initiation achieve CR, PR, or clinical response (PR + CR), each a number without dispersion.
次要结局
- Progression-free Survival (PFS)(82 months)
- Treatment-related Toxicity(18 months)
- Overall Survival (OS)(82 mo)
- O6-methylguanine DNA Methyltransferase (MGMT) Status by Immunohistochemistry (IHC)(18 months)
- O6-methylguanine DNA Methyltransferase (MGMT) by Promoter Methylation(18 months)
研究者
Shaheen Shagufta
Clinical Assistant Professor
Stanford University