A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01156090
First received: June 18, 2010
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition
Infusion Reaction

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactions [ Time Frame: February 2004 -April 2009 ] [ Designated as safety issue: No ]
    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


Enrollment: 141
Study Start Date: June 2010
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Vectibix
patients who received at least one treatment of Vectibix

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156090

Locations
United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, Georgia
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
United States, Missouri
St. Louis Cancer Care
Chesterfield, Missouri, United States, 63017
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Amgen
Investigators
Study Chair: Nancy Peacock, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT01156090     History of Changes
Other Study ID Numbers: SCRI Outcomes 04
Study First Received: June 18, 2010
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by SCRI Development Innovations, LLC:
vectibix

ClinicalTrials.gov processed this record on September 18, 2014