Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384238
• Other study ID #: IRB-42237
• Secondary ID: NCI-2017-01943PA
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 7, 2018
• Est. completion date: September 2027

Study information

• Verified date: January 2024
• Source: Stanford University
• Contact: gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
• Phone: (650) 498-7757
• Email: gitrialeligibility[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: September 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Procedure:
• Fluorescence Imaging
Undergo fluorescence imaging

Biological:
• Panitumumab
Given IV

Drug:
• Panitumumab-IRDye800
Given IV

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Eben Rosenthal	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	1 day
Secondary	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