RECRUITING

Panitumumab-IRDye800 in Patients With Pancreatic Cancer Undergoing Surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2018-02-07

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03384238

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

gitrialeligibility@stanford.edu gitrialeligibility@stanford.edu

CONTACT

(650) 498-7757

gitrialeligibility@stanford.edu

Principal Investigator

George Poultsides

PRINCIPAL_INVESTIGATOR

Stanford University

Eben Rosenthal

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University, School of Medicine

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Eben Rosenthal

George Poultsides, PRINCIPAL_INVESTIGATOR, Stanford University
Eben Rosenthal, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-07

Study Completion Date2027-09

Study Record Updates

Study Start Date2018-02-07

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

Pancreatic Adenocarcinoma