Using a special dye to improve surgery for pancreatic cancer
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
This study is testing a special dye to see if it can help doctors see pancreatic cancer better during surgery and make sure they remove all of it safely.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Drugs / interventions | panitumumab |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT03384238 on ClinicalTrials.gov |
What this trial studies
This phase I/II trial evaluates the safety and effectiveness of panitumumab-IRDye800, a combination of an antibody drug and an investigational dye, in enhancing the visibility of pancreatic cancer during surgery. The study aims to determine the optimal dose of the dye for identifying cancerous tissue compared to normal tissue. Patients will receive the dye before undergoing surgical resection, and advanced imaging techniques will be used to detect any remaining cancerous lesions. The trial will also assess the dye's safety and tolerability in patients with pancreatic adenocarcinoma.
Who should consider this trial
Good fit: Ideal candidates are patients with clinically suspected or biopsy-confirmed pancreatic adenocarcinoma who are scheduled for surgery.
Not a fit: Patients who have received investigational drugs recently or have significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective surgical removal of pancreatic tumors, potentially improving patient outcomes.
How similar studies have performed: While the use of fluorescence imaging in cancer surgery is being explored, this specific combination of panitumumab and IRDye800 is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford University, School of Medicine — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: George Poultsides — Stanford University
- Study coordinator: gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu
- Email: gitrialeligibility@stanford.edu
- Phone: (650) 498-7757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.