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A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Open (Enrolling by invite only)
Infusion Reaction

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Trial Information

A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Inclusion Criteria

Inclusion Criteria

- All patients treated with at least one treatment of Vectibix(Panitumumab) from
February 2004 -April 2009 are eligiblefor 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusino reactions

Outcome Description:

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

Outcome Time Frame:

February 2004 -April 2009

Safety Issue:


Principal Investigator

Nancy Peacock, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Institutional Review Board

Study ID:

SCRI Outcomes 04



Start Date:

June 2010

Completion Date:

March 2013

Related Keywords:

  • Infusion Reaction
  • vectibix



Northeast Arkansas Clinic Jonesboro, Arkansas  72401-3125
Northeast Georgia Medical Center Gainesville, Georgia  30501
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
Medical Oncology Associates of Augusta Augusta, Georgia  30901
St. Louis Cancer Care Chesterfield, Missouri  63017
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Baptist Hospital East Louisville, Kentucky  40207