panitumumab-irdye800 in patients with pancreatic cancer undergoing surgery

Conditions: Pancreatic Adenocarcinoma

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.

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.

Eligibility criteria:
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