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

• Status: Terminated
• Trial end date: 2017-05-22
• Target enrollment: 0
• Participant gender: All

Summary

This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cetuximab

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