Trial Search Results

Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

The purpose of this study is to test the safety and effectiveness of investigational dye, Panitumumab-IRDye800, in pancreatic cancer patients undergoing surgery to remove their cancer. Investigators believe Panitumumab-IRDye800 will bind to pancreatic cancer cell and fluoresce under near infrared (NIR) light. Being able to better visualize cancer cells during surgery could help surgeons remove subclinical (too small to see) and metastatic(separate from main tumor) cancer cells; leading to better treatment rates. In this study, participants will undergo the standard pancreatic cancer removalsurgery. Surgeons may elect to remove additional tissue based on Panitumumab-IRDye800 imaging, but only if the removal represents a minimal increase in risk (i.e., does not involve critical structures or significantly increase operation time, surgical wound area, or risk to participant).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Procedure: Fluorescence Imaging
  • Biological: Panitumumab
  • Drug: Panitumumab-IRDye800

Phase:

Phase 1/Phase 2

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

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Roan Courtney Raymundo
650-721-4071
Not Recruiting