Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Last updated: February 14, 2025
Sponsor: Eben Rosenthal
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pancreatitis

Cancer/tumors

Pancreatic Cancer

Treatment

Panitumumab

Panitumumab-IRDye800

Fluorescence Imaging

Clinical Study ID

NCT03384238
IRB-42237
NCI-2017-01943
R01CA190306
PANC0028
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Received an investigational drug within 30 days prior to first dose ofpanitumumab-IRDye800

  • Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestiveheart 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

Study Design

Total Participants: 27
Treatment Group(s): 3
Primary Treatment: Panitumumab
Phase: 1/2
Study Start date:
February 07, 2018
Estimated Completion Date:
September 30, 2027

Study 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.

Connect with a study center

  • Stanford University, School of Medicine

    Palo Alto, California 94304
    United States

    Active - Recruiting

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