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
George Poultsides
Summary
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.
Description
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. OUTLINE: This is a phas…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 institu…
Interventions
- ProcedureFluorescence Imaging
Undergo fluorescence imaging
- BiologicalPanitumumab
Given IV
- DrugPanitumumab-IRDye800
Given IV
Location
- Stanford University, School of MedicinePalo Alto, California