NCT02736578

Brief Summary

This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor. Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making the cancer visible when viewed through a fluorescent imaging system.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 1, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

April 4, 2016

Results QC Date

December 6, 2018

Last Update Submit

June 21, 2019

Conditions

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Peri-operative Cetuximab-IRDye800 Fluorescent Imaging, Both Doses

    Cetuximab-IRDye800 (50 mg or 100 mg) was administered pre-operatively, and the uptake of the dye was assessed by observed fluorescence intra-operatively (ie, in vivo) and post-operatively (ex vivo, or "back table"), in tumorous (tumor or tumor-bearing lymph nodes) or normal (non-tumorous) tissues. Collectively, intra-operative and immediately post-operative are considered "peri-operative." The outcome tumor-to-background ratio (TBR) is measured as the mean of the ratios observed between tumor and normal tissue for the participants, and the outcome is expressed as the mean with standard deviation.

    up to 5 days

Secondary Outcomes (7)

  • Cetuximab-IRDye800 Labeling Intensity in Tumor and Non-Tumor Tissues (Ex Vivo)

    up to 14 days

  • Effect of Cetuximab-IRDye800 Dose on Fluorescence Intensity

    up to 14 days

  • Sensitivity and Specificity of Ex Vivo Fluorescent Imaging

    up to 14 days

  • Cetuximab-IRDye800 Tumor Detection in Lymph Nodes

    up to 14 days

  • Signal-to-Noise Ratio (SNR) by Ex Vivo Photoacoustic Imaging (PAI)

    up to 5 days

  • +2 more secondary outcomes

Study Arms (2)

Cetuximab IRDye800, 50 mg

EXPERIMENTAL

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-IRDye800Drug: Cetuximab

Cetuximab IRDye800, 100 mg

EXPERIMENTAL

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-IRDye800Drug: Cetuximab

Interventions

Cetuximab-IRDye800DRUG

Administered intravenously (IV) at 50 or 100 mg

Also known as: Cetuximab-IRDye 800CW
Cetuximab IRDye800, 100 mgCetuximab IRDye800, 50 mg
CetuximabDRUG

Administered as a 100 mg IV loading dose

Also known as: Erbitux, C225
Cetuximab IRDye800, 100 mgCetuximab IRDye800, 50 mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94304, United States

Location

Related Publications (4)

  • Rosenthal EL, Kulbersh BD, King T, Chaudhuri TR, Zinn KR. Use of fluorescent labeled anti-epidermal growth factor receptor antibody to image head and neck squamous cell carcinoma xenografts. Mol Cancer Ther. 2007 Apr;6(4):1230-8. doi: 10.1158/1535-7163.MCT-06-0741.

    PMID: 17431103BACKGROUND

  • Rosenthal EL, Kulbersh BD, Duncan RD, Zhang W, Magnuson JS, Carroll WR, Zinn K. In vivo detection of head and neck cancer orthotopic xenografts by immunofluorescence. Laryngoscope. 2006 Sep;116(9):1636-41. doi: 10.1097/01.mlg.0000232513.19873.da.

    PMID: 16954995BACKGROUND

  • Tummers WS, Miller SE, Teraphongphom NT, Gomez A, Steinberg I, Huland DM, Hong S, Kothapalli SR, Hasan A, Ertsey R, Bonsing BA, Vahrmeijer AL, Swijnenburg RJ, Longacre TA, Fisher GA, Gambhir SS, Poultsides GA, Rosenthal EL. Intraoperative Pancreatic Cancer Detection using Tumor-Specific Multimodality Molecular Imaging. Ann Surg Oncol. 2018 Jul;25(7):1880-1888. doi: 10.1245/s10434-018-6453-2. Epub 2018 Apr 17.

    PMID: 29667116RESULT

  • Lwin TM, Hoffman RM, Bouvet M. The future of tumour-specific fluorescence-guided surgery for pancreatic cancer. Lancet Gastroenterol Hepatol. 2020 Aug;5(8):715-717. doi: 10.1016/S2468-1253(20)30123-0. Epub 2020 May 14. No abstract available.

    PMID: 32416765DERIVED

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Eben Rosenthal
Organization
Stanford University
elr@stanford.edu
650-723-2967

Study Officials

  • George Poultsides, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Otolaryngology

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 13, 2016

Study Start

July 1, 2016

Primary Completion

April 24, 2017

Study Completion

May 22, 2017

Last Updated

June 25, 2019

Results First Posted

February 1, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)