A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Infusion Reaction Clinical Trial

Official title:

A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156090
• Other study ID #: SCRI Outcomes 04
• Status: Completed
• Phase: N/A
• First received: June 18, 2010
• Last updated: August 27, 2015
• Start date: June 2010
• Est. completion date: January 2013

Study information

• Verified date: August 2015
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infusion Reaction

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactions	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	February 2004 -April 2009	No