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

Trial ID: NCT03384238

Interventional - Phase 1/2 - Recruiting

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

• Fluorescence Imaging
• Panitumumab
• Panitumumab-IRDye800

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

Sponsor

George Poultsides, National Cancer Institute (NCI)

Source: ClinicalTrials.gov

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