Immunoreactivity to Cetuximab in Cancer Patients | NCT00896896 | Trialant
NCT00896896
Sponsor
Vanderbilt-Ingram Cancer Center
Status
Completed
Last Update Posted
Apr 2, 2013Estimated
Enrollment
538Actual
Phase
Not provided
Conditions
Colorectal Cancer
Head and Neck Cancer
Interventions
immunologic technique
laboratory biomarker analysis
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00896896
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VICC HN 0668
Secondary IDs
ID
Type
Description
Link
VU-VICC-HN-0668
Brief Title
Immunoreactivity to Cetuximab in Cancer Patients
Official Title
Immunoreactivity to Cetuximab in Cancer Patients
Acronym
Not provided
Organization
Vanderbilt-Ingram Cancer CenterOTHER
Status Module
Record Verification Date
Mar 2013
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 2006
Primary Completion Date
Oct 2008Actual
Completion Date
Oct 2008Actual
First Submitted Date
May 9, 2009
First Submission Date that Met QC Criteria
May 9, 2009
First Posted Date
May 12, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 29, 2013
Last Update Posted Date
Apr 2, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer CenterPrincipal Investigator
Lead Sponsor
Vanderbilt-Ingram Cancer CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
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 Module
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
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
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
538Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
immunologic technique
Other
Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
None indicated
laboratory biomarker analysis
Other
Sera from head and neck cancer or colorectal cancer patients who were treated with cetuximab will be obtained from Tumor Tissue Repository
None indicated
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Identification of antibodies (e.g., IgE, IgG, IgA, and IgM) against cetuximab
Until all samples are collected.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Head and neck cancer or colorectal cancer patients who were treated with cetuximab
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Barbara Murphy, MD
Vanderbilt-Ingram Cancer Center
Principal Investigator
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D015179
Colorectal Neoplasms
D006258
Head and Neck Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
D018304
Esthesioneuroblastoma, Olfactory
D012468
Salivary Gland Neoplasms
D003110
Colonic Neoplasms
D012004
Rectal Neoplasms
Ancestor Terms
ID
Term
D007414
Intestinal Neoplasms
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D009371
Neoplasms by Site
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D007158
Immunologic Techniques
Ancestor Terms
ID
Term
D008919
Investigative Techniques
Browse Leaves
Not provided
Browse Branches
Not provided
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
stage IV adenoid cystic carcinoma of the oral cavity
stage IV basal cell carcinoma of the lip
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV verrucous carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
recurrent basal cell carcinoma of the lip
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent verrucous carcinoma of the oral cavity
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
stage I lymphoepithelioma of the nasopharynx
stage I squamous cell carcinoma of the nasopharynx
stage II lymphoepithelioma of the nasopharynx
stage II squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
stage I lymphoepithelioma of the oropharynx
stage I squamous cell carcinoma of the oropharynx
stage II lymphoepithelioma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage I inverted papilloma of the paranasal sinus and nasal cavity
stage I midline lethal granuloma of the paranasal sinus and nasal cavity
stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage II inverted papilloma of the paranasal sinus and nasal cavity
stage II midline lethal granuloma of the paranasal sinus and nasal cavity
stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage I salivary gland cancer
stage II salivary gland cancer
stage III salivary gland cancer
stage IV salivary gland cancer
recurrent salivary gland cancer
recurrent squamous cell carcinoma of the oropharynx