Trial Search Results

Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging and to see how well they work in finding pancreatic cancer in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a special imaging device.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eben Rosenthal

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Cetuximab-IRDye800
  • Drug: Cetuximab

Phase:

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

   - ≥ 19 years of age

   - Life expectancy of more than 12 weeks

   - EITHER

      - 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 (LLN) per institution normal lab values

   - Potassium > LLN

   - Calcium > LLN

   - Thyroid-stimulating hormone (TSH) < 13 micro International units/mL

EXCLUSION CRITERIA

   - Received an investigational drug within 30 days prior to first dose of cetuximab
   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 cetuximab or other monoclonal antibody therapies

   - Pregnant or breastfeeding

   - Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than
   440 ms in males or greater than 450 ms in females)

   - Lab values that in the opinion of the primary surgeon 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
CCTO
650-498-7061
Not Recruiting