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
| Registry | NCT03384238 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 / Phase 2 |
| Study type | Interventional; non randomized, sequential, masking: none, diagnostic |
| Enrollment | 27 (Estimated) |
| Sponsor | George Poultsides (Other); collaborators: National Cancer Institute (NCI) |
| Conditions | Pancreatic Adenocarcinoma |
| Interventions | Fluorescence Imaging, Panitumumab, Panitumumab-IRDye800 (Procedure, biological, drug) |
| Dates | start 2018-02-07, primary completion 2027-03-01 (estimated), completion 2027-09-01 (estimated), first posted 2017-12-27, last updated 2026-03-17 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Pancreatic Adenocarcinoma All trials of Fluorescence Imaging All trials of Panitumumab
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.
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 background ratio.
SECONDARY OBJECTIVES:
I. Determine the safety and tolerability of the panitumumab-IRDye800 as an imaging agent in subjects undergoing resection of pancreatic cancer.
II. Determine whether metastatic lesions, positive lymph node, or residual disease can be detected by near-infrared (NIR) fluorescence imaging with panitumumab-IRDye800 but not by white light.
OUTLINE: This is a phase I, dose-escalation study of panitumumab-IRDye800 followed by a phase II study.
Patients receive a loading dose of panitumumab intravenously (IV) over 60 minutes, and after 15 minutes of observation, patients then receive panitumumab-IRDye800 IV over 60 minutes on day 0. Patients then undergo surgical resection 2-5 days after panitumumab-IRDye800 administration with imaging using the Novadaq SPY/LUNA, Novadaq IR9000 fluorescence imaging system with open field handheld fluorescence imaging camera, and/or pinpoint endoscopic fluorescence imaging camera, and SurgVision Explorer Air multi spectral fluorescence reflectance system.
After completion of study treatment, patients are followed up at 15 and 30 days.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Cohort 1a | Experimental | Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800 | A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. Cohort 1a will receive 25 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices |
| Cohort 1b | Experimental | Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800 | Cohort 1b will receive 50 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices |
| Cohort 1c | Experimental | Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800 | Cohort 1c will receive 75 mg of Panitumumab IRDye800 with a 100 mg unlabeled test/loading dose of Panitumumab.A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices |
| Cohort 1d | Experimental | Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800 | Cohort 1d will receive a 50 mg dose of Panitumumab IRDye800 and no test/loading dose. A test/loading dose of 100 mg of unlabeled Panitumumab (fixed dose) will be administered via a 60 minute IV infusion prior to infusion of the Panitumumab IRDye800. The surgical resection will then occur 2 to 5 days after infusion. Intraoperative imaging will be performed using the intraoperative optical imaging devices |
| Cohort 2- Dose Expansion | Experimental | Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800 | Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1 |
Sex: All, ages: 19 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto, California | United States | Recruiting |
NIH grants: R01CA190306