Clinical trial NCT01156090: A Retrospective Cohort Study of Infusion Reactions Due to Vectibix
Official title: A Retrospective Cohort Study of Infusion Reactions Due to Vectibix
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infusion Reaction
Keywords: vectibix
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2010-07-02
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactions
timeFrame: February 2004 -April 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Northeast Arkansas Clinic
state: Arkansas
city: Augusta
country: United States
facility: Medical Oncology Associates of Augusta
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Louisville
country: United States
facility: Baptist Hospital East
state: Kentucky
city: Chesterfield
country: United States
facility: St. Louis Cancer Care
state: Missouri
city: Columbia
country: United States
facility: South Carolina Oncology Associates, PA
state: South Carolina
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Nancy Peacock, M.D.
role: STUDY_CHAIR
References: