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

Stopped early · Phase 2

Conditions studied: Pancreatic Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02736578

Run by

Eben Rosenthal

People needed

8

Starts

2016-07-01

Expected to finish

2017-05-22

Last updated by the study team

2019-06-25

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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