Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 8/1/2018 |
| Start Date: | February 7, 2018 |
| End Date: | February 7, 2022 |
| Contact: | Stefania Chirita |
| Email: | schirita@stanford.edu |
| Phone: | 650-723-1423 |
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
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.
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.
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.
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 primary surgeon would prevent surgical resection
- Patients receiving class IA (quinidine, procainamide) or class III (dofetilide,
amiodarone, sotalol) antiarrhythmic agents
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: George Poultsides
Phone: 650-723-1423
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