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Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Primary Purpose

Pancreatic Adenocarcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluorescence Imaging
Panitumumab
Panitumumab-IRDye800
Sponsored by
Eben Rosenthal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Adenocarcinoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1a

Cohort 1b

Cohort 1c

Cohort 1d

Cohort 2- Dose Expansion

Arm Description

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 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 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 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 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1

Outcomes

Primary Outcome Measures

Tumor to background ratio (TBR)
TBR is defined as fluorescence intensity of tumor tissue compared to that of normal surrounding pancreatic tissue.

Secondary Outcome Measures

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.
Number of positive lymph nodes per participant, not detected by white light
Determine whether positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light.
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.

Full Information

First Posted
December 19, 2017
Last Updated
May 31, 2023
Sponsor
Eben Rosenthal
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03384238
Brief Title
Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eben Rosenthal
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1a
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 1b
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 1c
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 1d
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2- Dose Expansion
Arm Type
Experimental
Arm Description
Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1
Intervention Type
Procedure
Intervention Name(s)
Fluorescence Imaging
Intervention Description
Undergo fluorescence imaging
Intervention Type
Biological
Intervention Name(s)
Panitumumab
Other Intervention Name(s)
ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF, Monoclonal Antibody ABX-EGF, Vectibix
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Panitumumab-IRDye800
Other Intervention Name(s)
Panitumumab IRDye 800, RDye800-Panitumumab Conjugate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Tumor to background ratio (TBR)
Description
TBR is defined as fluorescence intensity of tumor tissue compared to that of normal surrounding pancreatic tissue.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug
Description
Safety events will be recorded over the 30 day observation period.
Time Frame
Up to 30 days
Title
Number of positive lymph nodes per participant, not detected by white light
Description
Determine whether positive lymph nodes can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light.
Time Frame
1 day
Title
Number of positive resection margins per participant, not detected by white light
Description
Determine whether residual disease at resection margins can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Poultsides
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eben Rosenthal
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32416764
Citation
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.
Results Reference
derived

Learn more about this trial

Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

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