Gene Therapy Clinical Trials

Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

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.

Stanford is currently accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • procedure: Fluorescence Imaging
  • biological: Panitumumab
  • drug: Panitumumab-IRDye800

Eligibility


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

Ages Eligible for Study

19 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
gitrialeligibility@stanford.edu
650-498-7757
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