Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery
Recruiting
Phase 1Phase 2Interventional Study
Pancreatic Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
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At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
27 (estimated)
Sponsor
George Poultsides · Other
Who this trial is looking for
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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 mak…
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.
Trial Locations
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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 O…
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
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