Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Sponsor

Eben Rosenthal (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03384238

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

59.8

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma	Procedure: Fluorescence Imaging Biological: Panitumumab Drug: Panitumumab-IRDye800	Phase 1/Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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:

Determine the safety and tolerability of the panitumumab-IRDye800 as an imaging agent in subjects undergoing resection of pancreatic cancer.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Feb 7, 2018

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Procedure: Fluorescence Imaging Undergo fluorescence imaging Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix Drug: Panitumumab-IRDye800 Given IV Other Names: Panitumumab IRDye 800 RDye800-Panitumumab Conjugate
Experimental: 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	Procedure: Fluorescence Imaging Undergo fluorescence imaging Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix Drug: Panitumumab-IRDye800 Given IV Other Names: Panitumumab IRDye 800 RDye800-Panitumumab Conjugate
Experimental: 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	Procedure: Fluorescence Imaging Undergo fluorescence imaging Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix Drug: Panitumumab-IRDye800 Given IV Other Names: Panitumumab IRDye 800 RDye800-Panitumumab Conjugate
Experimental: 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	Procedure: Fluorescence Imaging Undergo fluorescence imaging Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix Drug: Panitumumab-IRDye800 Given IV Other Names: Panitumumab IRDye 800 RDye800-Panitumumab Conjugate
Experimental: Cohort 2- Dose Expansion Cohort 2 will receive the optimal dose of Panitumumab-IRDye800 as determined in Cohort 1	Procedure: Fluorescence Imaging Undergo fluorescence imaging Biological: Panitumumab Given IV Other Names: ABX-EGF ABX-EGF Monoclonal Antibody ABX-EGF, Clone E7.6.3 MoAb ABX-EGF Monoclonal Antibody ABX-EGF Vectibix Drug: Panitumumab-IRDye800 Given IV Other Names: Panitumumab IRDye 800 RDye800-Panitumumab Conjugate

Outcome Measures

Primary Outcome Measures

Tumor to background ratio (TBR) [1 day]
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 [Up to 30 days]
Safety events will be recorded over the 30 day observation period.
Number of positive lymph nodes per participant, not detected by white light [1 day]
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 [1 day]
Determine whether residual disease at resection margins can be detected by near-infrared (NIR) fluorescence imaging with Panitumumab-IRDye800 but not by white light.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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