Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Fluorescence Imaging
  Undergo fluorescence imaging
• Биопрепарат Panitumumab
  Given IV
• Препарат Panitumumab-IRDye800
  Given IV

Первичные конечные точки

• Tumor to background ratio (TBR) [Срок оценки: 1 day]

Вторичные конечные точки (3)

• Number of Grade 2 or higher AEs determined to be clinically significant and definitely, probably or possibly related to study drug [Срок оценки: Up to 30 days]
• Number of positive lymph nodes per participant, not detected by white light [Срок оценки: 1 day]
• Number of positive resection margins per participant, not detected by white light [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Stanford University, School of Medicine — Palo Alto

Публикации

• 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- PMID 32416764

Идентификаторы

NCT: NCT03384238 · IRB-42237 · NCI-2017-01943 · PANC0028 · R01CA190306

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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