Colorectal CancerNCT00896896
Immunoreactivity to Cetuximab in Cancer Patients
An observational study of Colorectal Cancer and Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Head and Neck Cancer
- What is being tested?
- immunologic technique and laboratory biomarker analysis
- How many people
- 538 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Head and neck cancer or colorectal cancer patients who were treated with cetuximab
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
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer, Head and Neck Cancer
- Being tested
- immunologic technique, laboratory biomarker analysis
- Keywords
- 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
- Medical subject headings
- Colorectal Neoplasms, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Esthesioneuroblastoma, Olfactory, Salivary Gland Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunologic techniqueOther
Also called None indicated
Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
laboratory biomarker analysisOther
Also called None indicated
Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of antibodies (e.g., IgE, IgG, IgA, and IgM) against cetuximab
Measured: Until all samples are collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Barbara Murphy, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896896
- Sponsor's protocol ID
- VICC HN 0668
- Other IDs
- VU-VICC-HN-0668
- Status last verified
- Mar 2013
- First submitted
- 9 May 2009
- Last updated
- 2 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoreactivity to Cetuximab in Cancer Patients
- ClinicalTrials.gov ID
- NCT00896896
- Acronym / sponsor ID
- VICC HN 0668
- Conditions
- Colorectal Cancer, Head and Neck Cancer
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck cancer or colorectal cancer patients who were treated with cetuximab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunologic techniqueAlso: None indicatedSera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository | Other | – |
| laboratory biomarker analysisAlso: None indicatedSera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository | Other | – |
Primary outcome
Identification of antibodies (e.g., IgE, IgG, IgA, and IgM) against cetuximab
Time frame: Until all samples are collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Murphy, MD principal investigator
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Head and Neck Cancer, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of antibodies (e.g., IgE, IgG, IgA, and IgM) against cetuximab (time frame: Until all samples are collected.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.