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

Not Recruiting

Trial ID: NCT02736578

Purpose

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.

Official Title

Intraoperative Pancreatic Cancer Detection Using Multimodality Molecular Imaging

Stanford Investigator(s)

George A. Poultsides, MD, MS
George A. Poultsides, MD, MS

Professor of Surgery (General Surgery)

Eligibility

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

Intervention(s):

drug: Cetuximab-IRDye800

drug: Cetuximab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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