Status:
RECRUITING
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Lead Sponsor:
Eben Rosenthal
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Adenocarcinoma
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief 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. Panit...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the optimal dose of panitumumab-IRDye800 in identifying pancreatic cancer compared to surrounding normal tissue in the ex vivo setting as measured by tumor to back...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03384238
Start Date
February 7 2018
End Date
September 1 2027
Last Update
February 17 2025
Active Locations (1)
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1
Stanford University, School of Medicine
Palo Alto, California, United States, 94304