Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

• Status: Active, not recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eben Rosenthal
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins; Panitumumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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