A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Completed

Conditions studied: Infusion Reaction

In brief

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.

Key facts

Study ID

NCT01156090

Run by

SCRI Development Innovations, LLC

People needed

141

Starts

2010-06-01

Expected to finish

2013-01-01

Last updated by the study team

2015-08-28

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Medical Oncology Associates of Augusta — Augusta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Baptist Hospital East — Louisville, Kentucky, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• South Carolina Oncology Associates, PA — Columbia, South Carolina, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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