Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Trial ID or NCT#

NCT03384238

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Phase I/II Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Pancreas Cancer During Surgical Procedures

Eligibility Criteria

Ages Eligible for Study: Older than 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

George A. Poultsides, MD, MS
George A. Poultsides, MD, MS
Hepatobiliary surgeon, Pancreatic surgeon, Liver surgeon, Sarcoma specialist, Gastrointestinal specialist, Minimally invasive surgeon
Professor of Surgery (General Surgery) at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

Contact

gitrialeligibility@stanford.edu
650-498-7757

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View on ClinicalTrials.gov