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A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01156090
Recruitment Status : Completed
First Posted : July 2, 2010
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to identify approximately 100 - 150 patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia from February 2004 - April 2009. Information regarding the incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will be captured. In patients who experienced hypersensitivity reactions, the following information will also be collected: premedication, treatment cycle symptoms that were experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or chemotherapy treatment, and outcome of the hypersensitivity reaction.

Condition or disease
Infusion Reaction

Study Design

Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Cohort Study of Infusion Reactions Due to Vectibix
Study Start Date : June 2010
Primary Completion Date : December 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Vectibix
patients who received at least one treatment of Vectibix


Outcome Measures

Primary Outcome Measures :
  1. Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactions [ Time Frame: February 2004 -April 2009 ]
    To determine the rate of Vectibix (Panitumumab)-related infusion reactions (CTCAE v3.0 grade I-IV) in geographic areas of the United States associated with a high rate of Erbitux-related infusion reactions


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia.
Criteria

Inclusion Criteria

  • All patients treated with at least one treatment of Vectibix(Panitumumab) from February 2004 -April 2009 are eligible for the study. Patients may or may not have had an infusion reaction to Vectibix (Panitumumab). Major infusion reactions are defined as rapid onset airway obstruction(bronchospasm, stridor, hoarseness), urticaria, erythema, and/or hypotension, anaphylaxis. Minor infusion reactions are defined as transient flushing or rash, urticaria, dyspnea, drug fever.
  • Patients who have received treatment with an EGFR in the past are eligible.

Exclusion Criteria

  • There will be no exclusions based on age, sex, medical history, or use of concomitant therapies. All charts will be abstracted for the same information, through completion of the last chemotherapy cycle.
Contacts and Locations

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): NCT01156090


Locations
United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Georgia
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Missouri
St. Louis Cancer Care
Chesterfield, Missouri, United States, 63017
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Amgen
Investigators
Study Chair: Nancy Peacock, M.D. SCRI Development Innovations, LLC
More Information

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01156090     History of Changes
Other Study ID Numbers: SCRI Outcomes 04
First Posted: July 2, 2010    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by SCRI Development Innovations, LLC:
vectibix

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs