RecruitingRecruiting
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
NCT03384238 · Stanford University
In plain English
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Official title
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
About this study
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 phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.
Patients receive a loading dose of panitumumab intravenously (IV) over 60 minutes, and after 15 minutes of observation, patients then receive panitumumab-IRDye800 IV over 60 minutes on day 0. Patients then undergo surgical resection 2-5 days after panitumumab-IRDye800 administration with imaging using the Novadaq SPY/LUNA, Novadaq IR9000 fluorescence imaging system with open field handheld fluorescence imaging camera, and/or pinpoint endoscopic fluorescence imaging camera, and SurgVision Explorer Air multi spectral fluorescence reflectance system.
After completion of study treatment, patients are followed up at 15 and 30 days.
Eligibility criteria
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 institution normal lab values
* Thyroid-stimulating hormone (TSH) \< 13 micro international units/mL
Exclusion Criteria:
* 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
Study design
Enrollment target: 27 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-02-07
Estimated completion: 2027-09
Last updated: 2026-03-17
Interventions
Procedure: Fluorescence ImagingBiological: PanitumumabDrug: Panitumumab-IRDye800
Primary outcomes
- • Tumor to background ratio (TBR) (1 day)
Sponsor
George Poultsides · other
With: National Cancer Institute (NCI)
Contacts & investigators
Contactgitrialeligibility@stanford.edu gitrialeligibility@stanford.edu · contact · gitrialeligibility@stanford.edu · (650) 498-7757
InvestigatorGeorge Poultsides · principal_investigator, Stanford University
All locations (1)
Stanford University, School of MedicineRecruiting
Palo Alto, California, United States