A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Tumor to background ratio (TBR)
研究概览
简要总结
This phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to see how well it works in finding cancer in patients with pancreatic cancer who are undergoing surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with pancreatic cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the optimal dose of panitumumab-IRDye800 in identifying pancreatic cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to background ratio.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of the panitumumab-IRDye800 as an imaging agent in subjects undergoing resection of pancreatic cancer.
II. Determine whether metastatic lesions, positive lymph node, or residual disease can be detected by near-infrared (NIR) fluorescence imaging with panitumumab-IRDye800 but not by white light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
- •Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
- •Life expectancy of more than 12 weeks
- •Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level =< 1
- •Hemoglobin >= 9 gm/dL
- •Platelet count >= 100,000/mm^3
- •Magnesium > the lower limit of normal per institution normal lab values
- •Potassium > the lower limit of normal per institution normal lab values
- •Calcium > the lower limit of normal per institution normal lab values
- •Thyroid-stimulating hormone (TSH) < 13 micro international units/mL
排除标准
- •Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
- •Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); or unstable angina within 6 months prior to enrollment
- •History of infusion reactions to panitumumab or other monoclonal antibody therapies
- •Pregnant or breastfeeding
- •Evidence of corrected QT (QTc) prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 460 ms in females)
- •Lab values that in the opinion of the physician would prevent surgical resection
- •Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
研究组 & 干预措施
Cohort 1a
A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Fluorescence Imaging (Procedure)
Cohort 1a
A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab (Biological)
Cohort 1a
A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 1b
Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Fluorescence Imaging (Procedure)
Cohort 1b
Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab (Biological)
Cohort 1b
Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 1c
Cohort 1c will receive 75 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab.A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Fluorescence Imaging (Procedure)
Cohort 1c
Cohort 1c will receive 75 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab.A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab (Biological)
Cohort 1c
Cohort 1c will receive 75 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab.A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 1d
Cohort 1d will receive a 50 mg dose of Panitumumab IRDye800 and no test/loading dose. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Fluorescence Imaging (Procedure)
Cohort 1d
Cohort 1d will receive a 50 mg dose of Panitumumab IRDye800 and no test/loading dose. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab (Biological)
Cohort 1d
Cohort 1d will receive a 50 mg dose of Panitumumab IRDye800 and no test/loading dose. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices
干预措施: Panitumumab-IRDye800 (Drug)
Cohort 2- Dose Expansion
Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1
干预措施: Fluorescence Imaging (Procedure)
Cohort 2- Dose Expansion
Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1
干预措施: Panitumumab (Biological)
Cohort 2- Dose Expansion
Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1
干预措施: Panitumumab-IRDye800 (Drug)
结局指标
主要结局
Tumor to background ratio (TBR)
时间窗: 1 day
TBR is defined as fluorescence intensity of tumor tissue compared to that of normal surrounding pancreatic tissue.
次要结局
- Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug(Up to 30 days)
- Number of positive resection margins per participant, not detected by white light(1 day)
- Number of positive lymph nodes per participant, not detected by white light(1 day)
研究者
George Poultsides
Chief of Surgical Oncology and Professor of Surgery
Stanford University