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Immunoreactivity to Cetuximab in Cancer Patients

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ClinicalTrials.gov Identifier: NCT00896896
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 2, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

Brief Summary:

RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.

PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.


Condition or disease Intervention/treatment
Colorectal Cancer Head and Neck Cancer Other: immunologic technique Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.

OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.


Study Type : Observational
Actual Enrollment : 538 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Immunoreactivity to Cetuximab in Cancer Patients
Study Start Date : November 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008



Intervention Details:
  • Other: immunologic technique
    Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
    Other Name: None indicated
  • Other: laboratory biomarker analysis
    Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
    Other Name: None indicated


Primary Outcome Measures :
  1. Identification of antibodies (e.g., IgE, IgG, IgA, and IgM) against cetuximab [ Time Frame: Until all samples are collected. ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Head and neck cancer or colorectal cancer patients who were treated with cetuximab
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:

    • Head and neck cancer
    • Advanced colorectal cancer
  • Previously treated with cetuximab
  • Serum samples available from patients enrolled in one of the following clinical trials:

    • VU-VICC-GI-0410 (colorectal cancer)
    • VU-VICC-GI-0622 (colorectal cancer)
    • VU-VICC-HN-0356 (head and neck cancer)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

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): NCT00896896


Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Barbara Murphy, MD Vanderbilt-Ingram Cancer Center

Responsible Party: Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00896896     History of Changes
Other Study ID Numbers: VICC HN 0668
VU-VICC-HN-0668
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: April 2, 2013
Last Verified: March 2013

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage I verrucous carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage II verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage I adenoid cystic carcinoma of the oral cavity
stage I basal cell carcinoma of the lip
stage I mucoepidermoid carcinoma of the oral cavity
stage I squamous cell carcinoma of the lip and oral cavity
stage I verrucous carcinoma of the oral cavity
stage II adenoid cystic carcinoma of the oral cavity
stage II basal cell carcinoma of the lip
stage II mucoepidermoid carcinoma of the oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage II verrucous carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage III basal cell carcinoma of the lip
stage III mucoepidermoid carcinoma of the oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage III verrucous carcinoma of the oral cavity

Additional relevant MeSH terms:
Colorectal Neoplasms
Head and Neck Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents