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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01943 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PANC0028 | Other Identifier | OnCore | |
| R01CA190306 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | 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 | 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 | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescence Imaging | Procedure | Undergo fluorescence imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor to background ratio (TBR) | TBR is defined as fluorescence intensity of tumor tissue compared to that of normal surrounding pancreatic tissue. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug | Safety events will be recorded over the 30 day observation period. | Up to 30 days |
| Number of positive lymph nodes per participant, not detected by white light |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu | Contact | (650) 498-7757 | gitrialeligibility@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| George Poultsides | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Recruiting | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32416764 | Derived | Lu G, van den Berg NS, Martin BA, Nishio N, Hart ZP, van Keulen S, Fakurnejad S, Chirita SU, Raymundo RC, Yi G, Zhou Q, Fisher GA, Rosenthal EL, Poultsides GA. Tumour-specific fluorescence-guided surgery for pancreatic cancer using panitumumab-IRDye800CW: a phase 1 single-centre, open-label, single-arm, dose-escalation study. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):753-764. doi: 10.1016/S2468-1253(20)30088-1. Epub 2020 May 14. |
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| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Cohort 1d |
| Experimental |
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 | Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1 |
|
| Panitumumab | Biological | Given IV |
|
|
| Panitumumab-IRDye800 | Drug | Given IV |
|
|
Determine whether positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light. |
| 1 day |
| Number of positive resection margins per participant, not detected by white light | Determine whether residual disease at resection margins can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light. | 1 day |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |