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Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Recruiting
I'm InterestedTrial ID: NCT03384238
Purpose
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.
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
Stanford Investigator(s)
George A. Poultsides, MD, MS
Professor of Surgery (General Surgery)
Eligibility
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
Intervention(s):
procedure: Fluorescence Imaging
biological: Panitumumab
drug: Panitumumab-IRDye800
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
gitrialeligibility@stanford.edu
650-498-7757