A Retrospective Cohort Study of Infusion Reactions Due to Vectibix
1 other identifier
observational
141
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2010
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 18, 2010
CompletedFirst Posted
Study publicly available on registry
July 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedAugust 28, 2015
August 1, 2015
2.5 years
June 18, 2010
August 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Vectibix
patients who received at least one treatment of Vectibix
Eligibility Criteria
Patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia.
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Amgencollaborator
Study Sites (7)
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Medical Oncology Associates of Augusta
Augusta, Georgia, 30901, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Baptist Hospital East
Louisville, Kentucky, 40207, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, 29210, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Study Officials
- STUDY CHAIR
Nancy Peacock, M.D.
SCRI Development Innovations, LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2010
First Posted
July 2, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2012
Study Completion
January 1, 2013
Last Updated
August 28, 2015
Record last verified: 2015-08