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Status unknownNCT03485638Updated Apr 2, 2019

Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection

An observational study in Tumor Disease Including Colorectal Cancer and Head & Neck Squamous Cell Carcinoma, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-02.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

  1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment for colorectal cancer and head and neck cancer. It is known that allergic reactions can occur in more than 5% of the patients, although the side effects are relatively low compared with other chemotherapeutic agents. It is known that cetuximab can induce hypersensitivity even at the first administration, unlike other anticancer drugs. In this study, we aimed to establish a model to predict patients with hypersensitivity reaction before administration of cetuximab and to provide safe chemotherapy.
  2. Recruitment method and consent procedure The study is designed for analysis patients scheduled for administration of cetuximab for the first time. Patients matching the selection and exclusion criteria with voluntary agreement to the study will be enrolled. Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab administration.
Read the detailed description
  • Acquisition of agreement Agreement, explanation, and consent form for study of human derived sample those that approved by the IRB are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample.

  • Observation and evaluation values

    ① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before administration of cetuximab

    ② Cetuximab Skin test using before cetuximab administration

    ③ Clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction)

    ④ Check patient's underlying disease and allergy history

  • Statistical analysis method Chi-square test, Fisher's exact test, Student t-test, Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will be used
02

Conditions studied

  • Tumor Disease Including Colorectal Cancer
  • Head & Neck Squamous Cell Carcinoma

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients scheduled for Cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.

Inclusion criteria

  • Adult men and women over 18 years of age
  • Patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.

Exclusion criteria

Exclusion Criteria:

  • Patients who did not consent to the study voluntarily after IRB approval
  • Persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.)
  • Those who can not read and understand the agreement
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
4 Weeks
Patient registry
Yes

Groups and cohorts

  • Cetuximab administration
05

What researchers measure

Primary outcomes

  1. Hypersensitivity reaction after cetuximab administration

    Adverse drug reaction after Cetuximab administration includes severe systemic allergic reaction such as anaphylaxis, urticaria, skin rash, dyspnea, shock and mental change.

    Time frame: Within 4 weeks after first administration

Secondary outcomes

  1. Cetuximab specific IgE

    Cetuximab specific IgE measured by ImmunoCAP assay, ELISA

    Time frame: within 4 weeks after first administration

06

Study locations

1 of 1 sites recruiting
  • Division of Allergy and Immunology, Department of Internal Medicine, Yonsei University
    Seoul, 03722, Korea, Republic of
    Recruiting
07

References and documents

Publications

  • George TJ Jr, Laplant KD, Walden EO, Davis AB, Riggs CE, Close JL, George SN, Lynch JW. Managing cetuximab hypersensitivity-infusion reactions: incidence, risk factors, prevention, and retreatment. J Support Oncol. 2010 Mar-Apr;8(2):72-7. PubMed 20464886 ↗
  • Hansen NL, Chandiramani DV, Morse MA, Wei D, Hedrick NE, Hansen RA. Incidence and predictors of cetuximab hypersensitivity reactions in a North Carolina academic medical center. J Oncol Pharm Pract. 2011 Jun;17(2):125-30. doi: 10.1177/1078155209360853. Epub 2010 Feb 10. PubMed 20147576 ↗
  • Chung CH, Mirakhur B, Chan E, Le QT, Berlin J, Morse M, Murphy BA, Satinover SM, Hosen J, Mauro D, Slebos RJ, Zhou Q, Gold D, Hatley T, Hicklin DJ, Platts-Mills TA. Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose. N Engl J Med. 2008 Mar 13;358(11):1109-17. doi: 10.1056/NEJMoa074943. PubMed 18337601 ↗
  • Pointreau Y, Commins SP, Calais G, Watier H, Platts-Mills TA. Fatal infusion reactions to cetuximab: role of immunoglobulin e-mediated anaphylaxis. J Clin Oncol. 2012 Jan 20;30(3):334; author reply 335. doi: 10.1200/JCO.2011.38.4701. Epub 2011 Dec 12. No abstract available. PubMed 22162592 ↗
  • Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A, Comby E, Bouhier-Leporrier K, Reimund JM, Le Mauff B. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs. 2011 Jul-Aug;3(4):396-401. doi: 10.4161/mabs.3.4.16293. Epub 2011 Jul 1. PubMed 21654207 ↗
  • Maier S, Chung CH, Morse M, Platts-Mills T, Townes L, Mukhopadhyay P, Bhagavatheeswaran P, Racenberg J, Trifan OC. A retrospective analysis of cross-reacting cetuximab IgE antibody and its association with severe infusion reactions. Cancer Med. 2015 Jan;4(1):36-42. doi: 10.1002/cam4.333. Epub 2014 Oct 9. PubMed 25296628 ↗
  • Jerath MR, Kwan M, Kannarkat M, Mirakhur B, Carey L, Valgus J, Platts-Mills TA, Tarrant TK. A desensitization protocol for the mAb cetuximab. J Allergy Clin Immunol. 2009 Jan;123(1):260-2. doi: 10.1016/j.jaci.2008.09.046. Epub 2008 Nov 20. No abstract available. PubMed 19022494 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03485638
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Nov 4, 2016
Primary completion
Nov 3, 2020 (estimated)
Completion
Nov 3, 2020 (estimated)
Last update
Apr 2, 2019

Study contacts

Jungwon Park, MD
Contact
PARKJW@yuhs.ac
+82 10 7389 3033

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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