Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

NCT03384238 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: IRB-42237NCI-2017-01943PANC0028R01CA190306
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Tumor to background ratio (TBR)

  TBR is defined as fluorescence intensity of tumor tissue compared to that of normal surrounding pancreatic tissue.

  1 day

Secondary Outcomes (3)

• Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug

  Up to 30 days

• Number of positive lymph nodes per participant, not detected by white light

  1 day

• Number of positive resection margins per participant, not detected by white light

  1 day

Study Arms (5)

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

Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800

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

Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800

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

Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800

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

Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800

Cohort 2- Dose Expansion

EXPERIMENTAL

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

Procedure: Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800

Interventions

Fluorescence Imaging PROCEDURE

Undergo fluorescence imaging

Cohort 1a; Cohort 1b; Cohort 1c; Cohort 1d; Cohort 2- Dose Expansion

Panitumumab BIOLOGICAL

Given IV

Also known as: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF, Monoclonal Antibody ABX-EGF, Vectibix

Cohort 1a; Cohort 1b; Cohort 1c; Cohort 1d; Cohort 2- Dose Expansion

Panitumumab-IRDye800 DRUG

Given IV

Also known as: Panitumumab IRDye 800, RDye800-Panitumumab Conjugate

Cohort 1a; Cohort 1b; Cohort 1c; Cohort 1d; Cohort 2- Dose Expansion

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• George Poultsides: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32416764 DERIVED

MeSH Terms

Interventions

Optical Imaging; Panitumumab

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• George Poultsides

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

CONTACT

(650) 498-7757; gitrialeligibility@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Surgical Oncology and Professor of Surgery

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 27, 2017
• Study Start: February 7, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)