Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00831571|
Recruitment Status : Active, not recruiting
First Posted : January 29, 2009
Last Update Posted : November 2, 2018
This research study will examine how often hypersensitivity, or allergic reactions, occur in patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can vary from a transient skin rash and fever to more severe symptoms such as shortness of breath, chest tightness, and a more severe allergic reaction that can affect blood pressure called anaphylaxis. We will be examining how often hypersensitivity reactions occur and how severe the reactions are when they occur. We will also examine whether there are factors that place people at risk for developing hypersensitivity reactions to oxaliplatin. In an optional portion to this study, we will examine whether allergy skin testing can predict whether someone will develop a hypersensitivity reaction.
Participants who develop a moderate to severe allergic reaction to oxaliplatin will be invited to participate in an additional portion of the study examining a desensitization process. This part of the study will examine whether a desensitization process can prevent future hypersensitivity reactions to oxaliplatin in patients who previously developed moderate to severe hypersensitivity reactions and allow therapy with oxaliplatin to continue.
|Condition or disease|
|Colorectal Cancer Esophageal Cancer Gastric Cancer Small Bowel Cancer Pancreatic Cancer|
- Participants will come in for chemotherapy treatment as scheduled by their oncologist. The frequency of the visits will depend upon the chemotherapy regimen the participant is receiving.
- With each visit, the participants will have a physical exam and will be asked questions about their general health and specific questions about any problems that they might be having and any medications they may be taking. At each of these visits, routine blood work will be taken to monitor the participant's health.
- While the participants are receiving oxaliplatin, the infusion nurse will monitor them for any evidence of hypersensitivity reaction. Participants will also leave with a diary to record any symptoms that may occur for 24 hours after they have completed the infusion of oxaliplatin.
- In the optional portion of the study, participants will undergo allergy skin testing in the Allergy Service at Brigham and Women's Hospital The skin testing will be done at three time points: before the first dose of oxaliplatin, before the 5th dose of oxaliplatin, and before the 10th dose of oxaliplatin.
- Desensitization is a method used to help a person with an allergy tolerate exposure to a specific allergic agent. Desensitization to a medication such as oxaliplatin involves giving the medication in slowly increasing amounts, starting with tiny doses, and ending with the full dose prescribed by the physician. Patients participating in this part of the study will have the desensitization at Brigham and Women's Hospital in the Medical Intensive Care Unit (ICU or MICU) to ensure close supervision. Desensitization to oxaliplatin involves a multi-step procedure where the oxaliplatin dose is started at very small doses and the rate of infusion is increased every 15 minutes until the "target rate" is achieved. This rate is then maintained until the full dose of medication has been infused. This usually takes approximately 6 hours if no adverse reactions are experienced.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||December 2019|
Patients receiving Oxaliplatin
Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin
- To determine prospectively the incidence and severity of hypersensitivity reactions to oxaliplatin among patients beginning treatment with oxaliplatin during a two-year observation period. [ Time Frame: 2 years ]
- To determine the relationship between cumulative dose of oxaliplatin and duration of therapy and development of hypersensitivity reactions. [ Time Frame: 2 years ]
- To determine the ability of oxaliplatin skin testing to identify patients at risk for developing hypersensitivity reactions. [ Time Frame: 2 years ]
- To determine the safety and efficacy of a rapid desensitization protocol to allow responding patients with moderate to severe hypersensitivity reactions to oxaliplatin to continue therapy with the drug. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831571
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jennifer A. Chan, MD, MPH||Dana-Farber Cancer Institute|