Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

NCT ID: NCT03384238

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2027-09-30

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.

Conditions

Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1a

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

Group Type: EXPERIMENTAL

Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo fluorescence imaging

Panitumumab

Intervention Type: BIOLOGICAL

Given IV

Panitumumab-IRDye800

Intervention Type: DRUG

Given IV

Cohort 1b

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

Group Type: EXPERIMENTAL

Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo fluorescence imaging

Panitumumab

Intervention Type: BIOLOGICAL

Given IV

Panitumumab-IRDye800

Intervention Type: DRUG

Given IV

Cohort 1c

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

Group Type: EXPERIMENTAL

Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo fluorescence imaging

Panitumumab

Intervention Type: BIOLOGICAL

Given IV

Panitumumab-IRDye800

Intervention Type: DRUG

Given IV

Cohort 1d

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

Group Type: EXPERIMENTAL

Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo fluorescence imaging

Panitumumab

Intervention Type: BIOLOGICAL

Given IV

Panitumumab-IRDye800

Intervention Type: DRUG

Given IV

Cohort 2- Dose Expansion

Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1

Group Type: EXPERIMENTAL

Fluorescence Imaging

Intervention Type: PROCEDURE

Undergo fluorescence imaging

Panitumumab

Intervention Type: BIOLOGICAL

Given IV

Panitumumab-IRDye800

Intervention Type: DRUG

Given IV

Interventions

Fluorescence Imaging

Undergo fluorescence imaging

Intervention Type: PROCEDURE

Panitumumab

Given IV

Intervention Type: BIOLOGICAL

Panitumumab-IRDye800

Given IV

Intervention Type: DRUG

Other Intervention Names

ABX-EGF; ABX-EGF Monoclonal Antibody; ABX-EGF, Clone E7.6.3; MoAb ABX-EGF; Monoclonal Antibody ABX-EGF; Vectibix; Panitumumab IRDye 800; RDye800-Panitumumab Conjugate

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eben Rosenthal

OTHER

Sponsor Role: lead

Responsible Party

Eben Rosenthal

Professor of Otolaryngology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

George Poultsides

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Eben Rosenthal

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

Role: CONTACT

gitrialeligibility@stanford.edu

(650) 498-7757

Facility Contacts

Role: primary

gitrialeligibility@stanford.edu

References

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.

Reference Type: DERIVED

PMID: 32416764 (View on PubMed)

Other Identifiers

NCI-2017-01943

Identifier Type: REGISTRY

Identifier Source: secondary_id

PANC0028

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA190306

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-42237

Identifier Type: -

Identifier Source: org_study_id