Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Recruiting now · Phase 1/Phase 2
Conditions studied: Pancreatic Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT03384238
- Run by
- George Poultsides
- People needed
- 27
- Starts
- 2018-02-07
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-03-17
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
- 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
You may not qualify if…
- 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
Where it is running
- Stanford University, School of Medicine — Palo Alto, California, United States (enrolling)
Full record on ClinicalTrials.gov
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