Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer, Neurology, Gastrointestinal, Pancreatic Cancer |
| Therapuetic Areas: | Gastroenterology, Neurology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | February 2009 |
| End Date: | December 2019 |
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.
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.
- 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.
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.
Inclusion Criteria:
- 18 years of age or older
- Histologically or cytologically confirmed colorectal cancer, esophageal cancer,
gastric cancer, small bowel cancer, hepatobiliary cancer and pancreatic cancer
- Patients must be eligible for treatment with oxaliplatin
- ECOG Performance Status of 2 or less
- Adequate bone marrow, renal and hepatic function as outlined in the protocol
- Patients must have recovered from both the acute and late effects of any prior
surgery, radiotherapy or other antineoplastic therapy
- Patients may participate in monitoring for hypersensitivity and skin testing if they
are receiving oxaliplatin as part of another clinical trial and allowed by that trial.
Patients cannot receive oxaliplatin through the desensitization protocol if they are
part of another clinical trial.
Exclusion Criteria:
- Prior treatment with oxaliplatin
- Active infection or with a fever of 101.3 or higher within 3 days of the first
scheduled days of protocol treatment
- Patients with active CNS metastases. Patients with stable CNS disease, who have
undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment
and who have been on a stable dose of corticosteroids for greater than 3 weeks are
eligible.
- Patients with known hypersensitivity to any of the components of oxaliplatin or
chemotherapeutic agent used in combination with oxaliplatin
- Patients who have received radiotherapy to more than 25% of their bone marrow; or
patients who received any radiotherapy within 4 weeks of study entry
- Peripheral neuropathy of grade 2 or higher
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with the patient's ability to sign informed
consent, cooperate and participate in teh study, or interfere with the interpretation
of the results.
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