An Open-label Phase II Trial of Panitumumab Plus Irinotecan for Patients With Advanced Metastatic Colorectal Cancer Without KRAS Mutation (Wild-type) in Third-line Chemotherapy (FOLFOX/XELOX ± Bevacizumab and Irinotecan Alone or FOLFIRI/CAPIRI ± Bevacizumab)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 9
- 主要终点
- Objective Response Rate (ORR) During the Combination Therapy Phase
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving panitumumab together with irinotecan may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying giving panitumumab together with irinotecan to see how well it works as third-line therapy in treating patients with metastatic colorectal cancer.
详细描述
OBJECTIVES:
Primary
- To assess the objective response rate when panitumumab is administered in combination with irinotecan hydrochloride as third-line therapy in patients with advanced metastatic colorectal cancer without KRAS mutation (wild type) previously treated with FOLFOX or XELOX chemotherapy with or without bevacizumab and irinotecan hydrochloride alone or FOLFIRI or CAPIRI chemotherapy with or without bevacizumab.
Secondary
- To assess the efficacy in terms of disease control rate, duration of response, time to response, progression-free survival, time to progression, time to treatment failure, and duration of stable disease.
- To assess the efficacy and safety of this regimen, followed by panitumumab alone in patients who discontinue third-line irinotecan hydrochloride due to toxicity.
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 80 Years（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
Panitumumab + CPT11 (irinotecan hydrochloride)
1 cycle every 14 days (J1= J15)
干预措施: Panitumumab (Drug)
Panitumumab + CPT11 (irinotecan hydrochloride)
1 cycle every 14 days (J1= J15)
干预措施: Irinotecan hydrochloride (Drug)
Panitumumab + CPT11 (irinotecan hydrochloride)
1 cycle every 14 days (J1= J15)
干预措施: Chromogenic in situ hybridization (Genetic)
Panitumumab + CPT11 (irinotecan hydrochloride)
1 cycle every 14 days (J1= J15)
干预措施: Fluorescence in situ hybridization (Genetic)
Panitumumab + CPT11 (irinotecan hydrochloride)
1 cycle every 14 days (J1= J15)
干预措施: Gene expression analysis (Genetic)
Panitumumab + CPT11 (irinotecan hydrochloride)
1 cycle every 14 days (J1= J15)
干预措施: Laboratory biomarker analysis (Other)
结局指标
主要结局
Objective Response Rate (ORR) During the Combination Therapy Phase
时间窗: Up to 20 months
Per the modified Response Evaluation Criteria in Solid Tumors (m-RECIST) for target lesions and radiogically assessed (CT Scans; optionally MRI): Complete Response (CR; Disappearance of all target lesions) or Partial Response (PR; At least a 30% decrease in the sum of the LD of target lesions) during the combination therapy phase.Overall Response (OR) = CR + PR.
次要结局
- Disease Control Rate (DCR)(Up to 20 months)
- Progression-free Survival (PFS)(Up to 20 months)
- Overall Survival (OS)(Up to 20 months)