Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

Launched by EBEN ROSENTHAL · Apr 7, 2016

Keywords

ClinConnect Summary

This is a dose-escalation study of 50 mg or 100 mg cetuximab-IRDye800.

Clearance of the tumor margin during surgical resection of pancreatic cancer is clinical importance, as margin-positive resections are suspected to be associated with rapid emergence of distant metastases shortly after surgery. However, pancreatic cancer is known to be difficult to visualize intraoperatively. Nonetheless, better detection of tumor tissue might improve the rate of complete tumor clearance, thereby improving outcomes. However, in order to be actionable, the data from such enhanced tumor detection must be ...

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
• • Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
• • ≥ 19 years of age
• • Life expectancy of more than 12 weeks
• • EITHER
• • 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 (LLN) per institution normal lab values
• • Potassium \> LLN
• • Calcium \> LLN
• • Thyroid-stimulating hormone (TSH) \< 13 micro International units/mL
• • EXCLUSION CRITERIA
• • Received an investigational drug within 30 days prior to first dose of cetuximab 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 cetuximab or other monoclonal antibody therapies
• • Pregnant or breastfeeding
• • Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females)
• • Lab values that in the opinion of the primary surgeon would prevent surgical resection
• • Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents