Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Trial ID or NCT#
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.
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
- - 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
- - 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
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Roan Courtney Raymundo