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Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT02736578
Recruitment Status : Terminated (Logistics)
First Posted : April 13, 2016
Last Update Posted : June 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eben Rosenthal, Stanford University

Brief Summary:
This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging and to see how well they work in finding pancreatic cancer in patients undergoing surgery. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a special imaging device.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Drug: Cetuximab-IRDye800 Drug: Cetuximab Phase 2

Detailed Description:

Clearance of the tumor margin during surgical resection of pancreatic cancer is clinical importance, as margin positive resections are suspected to be associated with rapid emergence of distant metastases shortly after surgery. However, pancreatic cancer is known to be difficult to visualize intraoperatively. Nonetheless, better detection of tumor tissue might improve the rate of complete tumor clearance, thereby improving outcomes. However, in order to be actionable, the data from such enhanced tumor detection must be available during the resection procedure. This study evaluates the use of a dye, Cetuximab-IRDye 800CW, that is administered pre-surgery, and is detectable during the surgical procedure.

Cetuximab is a chimeric (mouse/human) monoclonal antibody that targets the epidermal growth factor (EGF) receptor (EGFR). EGFR is highly-expressed in pancreatic ductal adenocarcinoma (PDAC) and is a good target for antibody-mediated imaging, due to its transmembrane position.

Cetuximab-IRDye 800CW is cetuximab labeled with IRDye800, an N-hydroxysuccinimide (NHS) ester infrared dye. IRDye800 has very similar properties compared to indocyanine green, and indocyanine green is readily detectable with a number of imaging systems. This study evaluates the Cetuximab-IRDye 800CW as a intraoperative labeling agent.

PRIMARY OBJECTIVES:

I. Determine the efficacy of cetuximab-IRDye800 in intraoperatively identifying pancreatic cancer compared to surrounding normal pancreatic and extrapancreatic tissue, as measured by tumor-to-background ratio.

SECONDARY OBJECTIVES:

I. Determine the tolerability of the cetuximab IRDye800 as an imaging agent in patients undergoing resection of pancreatic cancer.

OUTLINE: This is a dose-escalation study.

Patients receive cetuximab-IRDye 800CW intravenously (IV) over 30 minutes to 1 hour on day 0. Within 2 to 5 days, patients undergo surgery with intraoperative imaging.

After completion of study treatment, patients are followed up at days 10 and 30.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intraoperative Pancreatic Cancer Detection Using Multimodality Molecular Imaging
Study Start Date : July 2016
Actual Primary Completion Date : April 24, 2017
Actual Study Completion Date : May 22, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: Cetuximab IRDye800, 50 mg
On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 50 mg, followed by surgery with intraoperative imaging within 2 to 5 days.
Drug: Cetuximab-IRDye800
Administered intravenously (IV) at 50 or 100 mg
Other Name: Cetuximab-IRDye 800CW

Drug: Cetuximab
Administered as a 100 mg IV loading dose
Other Names:
  • Erbitux
  • C225

Experimental: Cetuximab IRDye800, 100 mg
On day 0, participants receive a 100 mg cetuximab loading dose by intravenous infusion (IV), followed 1 hour later by cetuximab-IRDye 800CW IV at 100 mg, followed by surgery with intraoperative imaging within 2 to 5 days.
Drug: Cetuximab-IRDye800
Administered intravenously (IV) at 50 or 100 mg
Other Name: Cetuximab-IRDye 800CW

Drug: Cetuximab
Administered as a 100 mg IV loading dose
Other Names:
  • Erbitux
  • C225




Primary Outcome Measures :
  1. Efficacy of cetuximab-IRDye 800CW in identifying cancer determined by signal-to-noise ratio on in vivo and ex vivo fluorescence and photoacoustic imaging [ Time Frame: Day of surgery ]
    Imaging results (categorical positive/negative) will be correlated with histopathological evidence of disease. Biological characteristics associated with fluorescence intensity, paraffin embedded blocks from the tumor will be obtained after routine pathologic analysis and will undergo analysis for: size of the epithelial tumor compartment in percent of total, tumor viability, and EGFR immunohistochemistry.

  2. Efficacy of cetuximab-IRDye 800CW in identifying cancer determined by tumor to background ratio on in vivo and ex vivo fluorescence and photoacoustic imaging [ Time Frame: Day of surgery ]
    Imaging results (categorical positive/negative) will be correlated with histopathological evidence of disease. Biological characteristics associated with fluorescence intensity, paraffin embedded blocks from the tumor will be obtained after routine pathologic analysis and will undergo analysis for: size of the epithelial tumor compartment in percent of total, tumor viability, and EGFR immunohistochemistry.


Secondary Outcome Measures :
  1. Number of grade 2 or higher adverse events determined to be clinically significant and definitely, probably, or possibly related to cetuximab-IRDye 800CW graded by Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: Up to 30 days ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma
  • Planned standard of care surgery with curative intent for pancreatic adenocarcinoma
  • ≥ 19 years of age
  • Life expectancy of more than 12 weeks
  • EITHER

    • 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 (LLN) per institution normal lab values
  • Potassium > LLN
  • Calcium > LLN
  • Thyroid-stimulating hormone (TSH) < 13 micro International units/mL

EXCLUSION CRITERIA

  • Received an investigational drug within 30 days prior to first dose of cetuximab 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 cetuximab or other monoclonal antibody therapies
  • Pregnant or breastfeeding
  • Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than 440 ms in males or greater than 450 ms in females)
  • Lab values that in the opinion of the primary surgeon would prevent surgical resection
  • Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736578


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94304
Sponsors and Collaborators
Eben Rosenthal
National Cancer Institute (NCI)
Investigators
Principal Investigator: George Poultsides, MD Stanford University

Responsible Party: Eben Rosenthal, Professor of Otolaryngology, Stanford University
ClinicalTrials.gov Identifier: NCT02736578     History of Changes
Other Study ID Numbers: IRB-35789
NCI-2016-00433 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PANC0024 ( Other Identifier: OnCore )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cetuximab
Antineoplastic Agents