Colorectal CancerNCT00831571
Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
An observational study of Colorectal Cancer and Esophageal Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at Dana-Farber Cancer Institute with the chemotherapy drug oxaliplatin.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
- 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.
- Conditions
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Small Bowel Cancer, Pancreatic Cancer
- Keywords
- oxaliplatin, hypersensitivity
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Patients receiving Oxaliplatin | |
| Desensitization | Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine prospectively the incidence and severity of hypersensitivity reactions to oxaliplatin among patients beginning treatment with oxaliplatin during a two-year observation period.
Measured: 2 years
Secondary outcomes (3)
To determine the relationship between cumulative dose of oxaliplatin and duration of therapy and development of hypersensitivity reactions.
Measured: 2 years
To determine the ability of oxaliplatin skin testing to identify patients at risk for developing hypersensitivity reactions.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Principal investigator, Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Jennifer A. Chan, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831571
- Sponsor's protocol ID
- 08-140
- Other IDs
- SANOFI OX-07-008
- Status last verified
- Apr 2022
- First submitted
- 27 Jan 2009
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
- ClinicalTrials.gov ID
- NCT00831571
- Acronym / sponsor ID
- 08-140
- Conditions
- Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Small Bowel Cancer, Pancreatic Cancer
- Keywords
- oxaliplatin, hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Patients receiving Oxaliplatin |
| Desensitization | – | –Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at Dana-Farber Cancer Institute with the chemotherapy drug oxaliplatin.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A. Chan, MD, MPH principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Esophageal Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.