What this study is
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.
What's being tested
- Fluorescence Imaging
Intervention · PROCEDURE
Undergo fluorescence imaging
- Panitumumab
Intervention · BIOLOGICAL
- Panitumumab-IRDye800
Intervention · DRUG
Both Panitumumab and Panitumumab-IRDye800
Given IV
Study details
- 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
- Sponsor
- George Poultsides
- Conditions
- Pancreatic Adenocarcinoma
- Enrolling
- 27 people
- Starts
- 2018-02-07
- Est. completion
- 2027-09
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openStanford University, School of Medicine
Palo Alto, California, United States
- Contactgitrialeligibility@stanford.edu
- George Poultsides · Principal investigator
Recruiting
Study team
Sponsor
George Poultsides
Study ID IRB-42237
Principal investigator
George Poultsides
Stanford University
CONTACT
gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.