A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01156090

Enrollment

141

Registered

2010-07-02

Start date

2010-06-30

Completion date

2013-01-31

Last updated

2015-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infusion Reaction

Keywords

vectibix

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactions	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

Countries

United States

Outcome results