A Phase I Study of Induction AMG 479 and Gemcitabine, Followed by AMG 479, Capecitabine, and 3D-Conformal Radiation Therapy (3D-CRT) With Subsequent Maintenance Therapy for Locally Advanced Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 10
- 主要终点
- Dose-limiting toxicity of ganitumab and capecitabine given concurrently with radiotherapy
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as ganitumab, 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 cancer-killing substances to them. Drugs used in chemotherapy, such as gemcitabine hydrochloride and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy, such as 3-dimensional conformal radiation therapy, that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of ganitumab when given together with gemcitabine hydrochloride followed by radiation therapy, ganitumab, capecitabine, and maintenance therapy in treating patients with locally advanced cancer of the pancreas.
详细描述
OBJECTIVES:
Primary
- To evaluate the maximum dose of ganitumab, up to a target dose of 20 mg/kg, given concurrently with capecitabine and radiotherapy following induction ganitumab and gemcitabine hydrochloride in patients with locally advanced pancreatic cancer.
Secondary
- To evaluate the safety profile of induction therapy comprising ganitumab and gemcitabine hydrochloride, followed by ganitumab and concurrent chemoradiation, and subsequently by maintenance ganitumab and gemcitabine hydrochloride until disease progression in patients with locally advanced pancreatic cancer.
- To evaluate response and overall survival of patients treated at the maximum dose of ganitumab given concurrently with capecitabine and radiotherapy following induction ganitumab and subsequently followed by maintenance ganitumab and gemcitabine hydrochloride until disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
Arm B
Dose level 1A (Ganitumab 12 mg/kg, Capecitabine 825mg/m2)
干预措施: ganitumab (Biological)
Arm F
Dose level 2B (Ganitumab 20 mg/kg, Capecitabine 625mg/m2)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm A
Dose level -1A (Ganitumab 6 mg/kg, Capecitabine 825mg/m2)
干预措施: ganitumab (Biological)
Arm A
Dose level -1A (Ganitumab 6 mg/kg, Capecitabine 825mg/m2)
干预措施: capecitabine (Drug)
Arm A
Dose level -1A (Ganitumab 6 mg/kg, Capecitabine 825mg/m2)
干预措施: gemcitabine hydrochloride (Drug)
Arm A
Dose level -1A (Ganitumab 6 mg/kg, Capecitabine 825mg/m2)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm B
Dose level 1A (Ganitumab 12 mg/kg, Capecitabine 825mg/m2)
干预措施: capecitabine (Drug)
Arm B
Dose level 1A (Ganitumab 12 mg/kg, Capecitabine 825mg/m2)
干预措施: gemcitabine hydrochloride (Drug)
Arm B
Dose level 1A (Ganitumab 12 mg/kg, Capecitabine 825mg/m2)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm C
Dose level 2A (Ganitumab 20 mg/kg, Capecitabine 825mg/m2)
干预措施: ganitumab (Biological)
Arm C
Dose level 2A (Ganitumab 20 mg/kg, Capecitabine 825mg/m2)
干预措施: capecitabine (Drug)
Arm C
Dose level 2A (Ganitumab 20 mg/kg, Capecitabine 825mg/m2)
干预措施: gemcitabine hydrochloride (Drug)
Arm C
Dose level 2A (Ganitumab 20 mg/kg, Capecitabine 825mg/m2)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm D
Dose level -1B (Ganitumab 6 mg/kg, Capecitabine 625mg/m2)
干预措施: ganitumab (Biological)
Arm D
Dose level -1B (Ganitumab 6 mg/kg, Capecitabine 625mg/m2)
干预措施: capecitabine (Drug)
Arm D
Dose level -1B (Ganitumab 6 mg/kg, Capecitabine 625mg/m2)
干预措施: gemcitabine hydrochloride (Drug)
Arm F
Dose level 2B (Ganitumab 20 mg/kg, Capecitabine 625mg/m2)
干预措施: gemcitabine hydrochloride (Drug)
Arm D
Dose level -1B (Ganitumab 6 mg/kg, Capecitabine 625mg/m2)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm E
Dose level 1B (Ganitumab 12 mg/kg, Capecitabine 625mg/m2)
干预措施: ganitumab (Biological)
Arm E
Dose level 1B (Ganitumab 12 mg/kg, Capecitabine 625mg/m2)
干预措施: capecitabine (Drug)
Arm E
Dose level 1B (Ganitumab 12 mg/kg, Capecitabine 625mg/m2)
干预措施: gemcitabine hydrochloride (Drug)
Arm E
Dose level 1B (Ganitumab 12 mg/kg, Capecitabine 625mg/m2)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm F
Dose level 2B (Ganitumab 20 mg/kg, Capecitabine 625mg/m2)
干预措施: ganitumab (Biological)
Arm F
Dose level 2B (Ganitumab 20 mg/kg, Capecitabine 625mg/m2)
干预措施: capecitabine (Drug)
结局指标
主要结局
Dose-limiting toxicity of ganitumab and capecitabine given concurrently with radiotherapy
时间窗: From start of chemoradiation to 21 days after the end of chemoradiation
次要结局
- Response rate (for patients treated at maximum-tolerated dose of ganitumab)(Analysis occurs after all patients have been potentially followed for 1 year)
- Overall survival (for patients treated at maximum-tolerated dose of ganitumab)(Analysis occurs after all patients have been potentially followed for 1 year)