Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
18 Years
N/A
Both
Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Small Bowel Cancer, Pancreatic Cancer
Trial Information
Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
- 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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
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.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Jennifer A. Chan, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
08-140
NCT ID:
NCT00831571
Start Date:
February 2009
Completion Date:
Related Keywords:
- Colorectal Cancer
- Esophageal Cancer
- Gastric Cancer
- Small Bowel Cancer
- Pancreatic Cancer
- oxaliplatin
- hypersensitivity
- Colorectal Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Hypersensitivity
- Stomach Neoplasms
- Pancreatic Neoplasms
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
